Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments (DETAIL)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Pacific Eye Associates
ClinicalTrials.gov Identifier:
NCT00590694
First received: December 26, 2007
Last updated: April 10, 2012
Last verified: April 2012

December 26, 2007
April 10, 2012
October 2006
December 2009   (final data collection date for primary outcome measure)
Mean change in visual acuity from baseline over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00590694 on ClinicalTrials.gov Archive Site
  • Time to OCT resolution of macular edema and pigment epithelial detachment [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion of patients with complete resolution of PED at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Durability of outcome: time from last ranibizumab injection to retreatment [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis

Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Age-related Macular Degeneration
  • Pigment Epithelial Detachment
  • Neovascular Macular Degeneration
  • Wet Macular Degeneration
Drug: ranibizumab
0.5mg injection monthly according to protocol for one year
Other Name: Lucentis injection
  • Active Comparator: Group1
    Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
    Intervention: Drug: ranibizumab
  • Active Comparator: Group 2
    Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
    Intervention: Drug: ranibizumab
Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Neovascular age-related macular degeneration patients over age 50
  • Presence of a pigment epithelial detachment on optical coherence tomography
  • Initial or recurrent disease
  • Previous treatment allowed
  • Visual acuity between Snellen 20/40 - 20/400

Exclusion Criteria:

  • More than three previous treatments with PDT or other radiation/laser therapy
  • Previous vitrectomy or other AMD surgical intervention
  • Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)

Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590694
DETAIL Study for PED in AMD
No
Pacific Eye Associates
Pacific Eye Associates
Genentech, Inc.
Principal Investigator: Anne Fung, MD Pacific Eye Associates / California Pacific Medical Center
Pacific Eye Associates
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP