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CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl) (COCTAEyl)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803631
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:
The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

Condition or disease
AMD Exudative Macular Degeneration

Layout table for study information
Study Type : Observational
Estimated Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. presence of flow on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  2. presence of collaterals on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  3. presence of peripheral arcade on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  4. presence of arteriolization on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  5. presence of vascular loops on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  6. presence of dark halo on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  7. presence of feeder vessel on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  8. presence of flow void on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  9. measure of neovascular area on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  10. measure of neovascular density on OCTA [ Time Frame: at month 13 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time


Secondary Outcome Measures :
  1. presence of flow on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  2. presence of flow on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  3. presence of flow on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  4. presence of flow on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  5. presence of flow on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  6. presence of flow on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  7. presence of flow on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  8. presence of flow on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  9. presence of flow on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  10. presence of flow on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  11. presence of flow on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  12. presence of flow on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  13. presence of flow on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  14. presence of collaterals on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  15. presence of collaterals on OCTA [ Time Frame: at month1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  16. presence of collaterals on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  17. presence of collaterals on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  18. presence of collaterals on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  19. presence of collaterals on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  20. presence of collaterals on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  21. presence of collaterals on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  22. presence of collaterals on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  23. presence of collaterals on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  24. presence of collaterals on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  25. presence of collaterals on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  26. presence of collaterals on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  27. presence of peripheral arcade on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  28. presence of peripheral arcade on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  29. presence of peripheral arcade on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  30. presence of peripheral arcade on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  31. presence of peripheral arcade on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  32. presence of peripheral arcade on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  33. presence of peripheral arcade on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  34. presence of peripheral arcade on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  35. presence of peripheral arcade on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  36. presence of peripheral arcade on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  37. presence of peripheral arcade on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  38. presence of peripheral arcade on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  39. presence of peripheral arcade on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  40. presence of arteriolization on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  41. presence of arteriolization on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  42. presence of arteriolization on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  43. presence of arteriolization on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  44. presence of arteriolization on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  45. presence of arteriolization on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  46. presence of arteriolization on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  47. presence of arteriolization on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  48. presence of arteriolization on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  49. presence of arteriolization on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  50. presence of arteriolization on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  51. presence of arteriolization on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  52. presence of vascular loops on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  53. presence of vascular loops on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  54. presence of vascular loops on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  55. presence of vascular loops on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  56. presence of vascular loops on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  57. presence of vascular loops on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  58. presence of vascular loops on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  59. presence of vascular loops on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  60. presence of vascular loops on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  61. presence of vascular loops on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  62. presence of vascular loops on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  63. presence of dark halo on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  64. presence of dark halo on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  65. presence of dark halo on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  66. presence of dark halo on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  67. presence of dark halo on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  68. presence of dark halo on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  69. presence of dark halo on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  70. presence of dark halo on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  71. presence of dark halo on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  72. presence of dark halo on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  73. presence of dark halo on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  74. presence of dark halo on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  75. presence of dark halo on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  76. presence of feeder vessel on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  77. presence of feeder vessel on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  78. presence of feeder vessel on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  79. presence of feeder vessel on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  80. presence of feeder vessel on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  81. presence of feeder vessel on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  82. presence of feeder vessel on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  83. presence of feeder vessel on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  84. presence of feeder vessel on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  85. presence of feeder vessel on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  86. presence of feeder vessel on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  87. presence of feeder vessel on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  88. presence of feeder vessel on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  89. presence of flow void on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  90. presence of flow void on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  91. presence of flow void on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  92. presence of flow void on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  93. presence of flow void on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  94. presence of flow void on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  95. presence of flow void on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  96. presence of flow void on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  97. presence of flow void on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  98. presence of flow void on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  99. presence of flow void on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  100. presence of flow void on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  101. presence of flow void on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  102. measure of neovascular area on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  103. measure of neovascular area on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  104. measure of neovascular area on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  105. measure of neovascular area on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  106. measure of neovascular area on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  107. measure of neovascular area on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  108. measure of neovascular area on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  109. measure of neovascular area on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  110. measure of neovascular area on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  111. measure of neovascular area on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  112. measure of neovascular area on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  113. measure of neovascular area on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  114. measure of neovascular area on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  115. measure of neovascular density on OCTA [ Time Frame: baseline ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  116. measure of neovascular density on OCTA [ Time Frame: at month 1 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  117. measure of neovascular density on OCTA [ Time Frame: at month 2 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  118. measure of neovascular density on OCTA [ Time Frame: at month 3 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  119. measure of neovascular density on OCTA [ Time Frame: at month 4 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  120. measure of neovascular density on OCTA [ Time Frame: at month 5 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  121. measure of neovascular density on OCTA [ Time Frame: at month 6 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  122. measure of neovascular density on OCTA [ Time Frame: at month 7 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  123. measure of neovascular density on OCTA [ Time Frame: at month 8 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  124. measure of neovascular density on OCTA [ Time Frame: at month 9 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  125. measure of neovascular density on OCTA [ Time Frame: at month 10 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  126. measure of neovascular density on OCTA [ Time Frame: at month 11 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  127. measure of neovascular density on OCTA [ Time Frame: at month 12 ]
    high flow on OCTA corresponding to the neovascular network with vascular remodeling over time

  128. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 13 ]
  129. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at baseline ]
  130. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 1 ]
  131. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 2 ]
  132. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 3 ]
  133. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 4 ]
  134. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 5 ]
  135. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 6 ]
  136. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 7 ]
  137. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 8 ]
  138. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 9 ]
  139. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 10 ]
  140. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 11 ]
  141. Intraretinal and/or subretinal fluid in SD-OCT [ Time Frame: at month 12 ]
  142. visual acuity in logmar [ Time Frame: at baseline ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  143. visual acuity in logmar [ Time Frame: at month 1 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  144. visual acuity in logmar [ Time Frame: at month 2 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  145. visual acuity in logmar [ Time Frame: at month 3 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  146. visual acuity in logmar [ Time Frame: at month 4 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  147. visual acuity in logmar [ Time Frame: at month 5 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  148. visual acuity in logmar [ Time Frame: at month 6 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  149. visual acuity in logmar [ Time Frame: at month 7 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  150. visual acuity in logmar [ Time Frame: at month 8 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  151. visual acuity in logmar [ Time Frame: at month 9 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  152. visual acuity in logmar [ Time Frame: at month 10 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  153. visual acuity in logmar [ Time Frame: at month 11 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  154. visual acuity in logmar [ Time Frame: at month 12 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  155. visual acuity in logmar [ Time Frame: at month 13 ]
    Measure of best-corrected visual acuity (BCVA) measured on ETDRS

  156. presence or abscence of hemorrhage, fibrosis and atrophy on fundus color photography [ Time Frame: at 1 months ]
  157. presence or abscence of hemorrhage on fundus color photography [ Time Frame: at 1 months ]
  158. presence or abscence of fibrosis on fundus color photography [ Time Frame: at 1 months ]
  159. presence or abscence of atrophy on fundus color photography [ Time Frame: at 1 months ]
  160. presence or abscence of hemorrhage on fundus color photography [ Time Frame: at 13 months ]
  161. presence or abscence of fibrosis on fundus color photography [ Time Frame: at 13 months ]
  162. presence or abscence of atrophy on fundus color photography [ Time Frame: at 13 months ]
  163. type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) [ Time Frame: Baseline ]
  164. type of choroidal neovascularization on fluorescein angiography (type 1, type 2 or mixed lesions) [ Time Frame: at month 13 ]
  165. type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) [ Time Frame: baseline ]
  166. type of choroidal neovascularization on indocyanine green angiography (type 1, type 2 or mixed lesions) [ Time Frame: at month 13 ]
  167. choroidal thickness on EDI-OCT [ Time Frame: monthly during 13 months ]
  168. type of choroidal neovascularization on SD-OCT (type 1, type 2 or mixed lesions) [ Time Frame: monthly during 13 months ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with wet-AMD (NVC type 1 or 2) diagnosed maximum one week before inclusion and for whom Aflibercept in intra-vitreal injection technic has been prescribed.
Criteria

Inclusion Criteria:

  • Naïve patients
  • Type 1 or type 2 Choroidal NeoVascularization (CNV)
  • Age ≥ 55 years
  • Presence of subfoveal CNV secondary to Age-related Macular Degeneration (AMD)
  • At the time of inclusion, multimodal imaging should reveal exudative features
  • Exudative AMD diagnosis established between 1 and 7 days before inclusion
  • Monitored monthly
  • Loading phase then bimonthly retreatment.
  • Signed Informed Consent.
  • Patient covered by the French Health Insurance

Exclusion Criteria:

  • Polypoidal choroidal vasculopathy
  • Type 3 neovascularization
  • Choroidal neovascularization attributable to causes other than AMD
  • Macular hematoma
  • Pigment epithelial detachment higher than 150µm
  • Fibrosis > 50% lesion on fundus color photography, fibroglial scar
  • Media opacity annoying acquisition
  • Retinal vascular occlusion
  • Diabetic retinopathy
  • Adult-onset foveomacular vitelliform dystrophy and other pattern dystrophies,
  • Refractive error >-6D
  • Active intraocular inflammation in the study eye
  • Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
  • Patient taking part in an interventional study at the time of enrolment.
  • Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
  • Pregnant and lactating women
  • Stroke and/or myocardial infarction 3 months before inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803631


Contacts
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Contact: Eric SOUIED 01 45 17 50 00 eric.souied@chicreteil.Fr
Contact: Camille JUNG 01 45 17 50 00 camille.jung@chicreteil.fr

Locations
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France
Hôpital Pellegrin, CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Jean-Francois KOROBELNIK    05 57 82 12 17 ext 33    jean-francois.korobelnik@chu-bordeaux.fr   
CHI de Créteil Recruiting
Créteil, France, 94000
Contact: Eric SOUIED    01 45 17 50 00 ext 33    eric.souied@chicreteil.fr   
Contact: Polina ASTROZ    01 45 17 50 00    polina.astroz@chicreteil.fr   
Hôpital La Croix Rousse Recruiting
Lyon, France, 69004
Contact: Laurent KODJIKIAN    04 72 07 17 18 ext 33    laurent.kodjikian@chu-Lyon.fr   
Hôpital Lariboisière, APHP Not yet recruiting
Paris, France, 75010
Contact: Ramin TADAYONI    01 49 95 64 86 ext 33    sec.tadayoni@gmail.com   
Centre Ophtalmologique d'Imagerie et de Laser, Not yet recruiting
Paris, France, 75015
Contact: Salomon Yves COHEN    01 42 84 94 00    sycsyc75@gmail.com   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Bayer
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03803631    
Other Study ID Numbers: COCTAEyl
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases