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Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01810042
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : April 7, 2014
Last Update Posted : May 4, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Ji Eun Lee, Pusan National University Hospital

Brief Summary:
Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

Condition or disease Intervention/treatment Phase
Exudative Age-related Macular Degeneration Drug: ranibizumab Phase 4

Detailed Description:
For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration
Study Start Date : October 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013


Arm Intervention/treatment
Experimental: ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
Drug: ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Other Name: intravitreal injection of ranibizumab (Lucentis, Novartis)




Primary Outcome Measures :
  1. Caliber of Choroidal New Vessel (CNV) [ Time Frame: 6 months ]
    Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.


Secondary Outcome Measures :
  1. Lesion Size of CNV [ Time Frame: 6 months ]
    Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.

  2. Visual Acuity in ETDRS Letters [ Time Frame: 6 months ]
    Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.

  3. Visual Acuity Changes [ Time Frame: baseline and 6 months ]

    Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.

    Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline.




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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age >= 50
  2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
  3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
  4. Area of CNV clearly visible in ICGA is more than half of the total CNV area.

Exclusion Criteria:

  1. CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
  2. Blocked fluorescence in ICGA is more than half of the total CNV area.
  3. Disciform scar
  4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
  5. Previous any treatment of photodynamic therapy or photocoagulation
  6. Previous intraocular or periocular injection of steroid within 3 months
  7. Previous intraocular surgery except cataract surgery
  8. Vitreo-retinal interface disease on the macula
  9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
  10. Uncontrolled periocular or intraocular infection
  11. History of hypersensitivity to ranibizumab treatment
  12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

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): NCT01810042


Locations
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Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Haeundae Baik Hospital
Busan, Korea, Republic of, 612-896
Sponsors and Collaborators
Pusan National University Hospital
Novartis
Investigators
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Principal Investigator: Ji Eun Lee, MH, PhD Pusan National Universtiy Hospital

Publications:
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Responsible Party: Ji Eun Lee, Associate professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01810042    
Other Study ID Numbers: 임상20120178
First Posted: March 13, 2013    Key Record Dates
Results First Posted: April 7, 2014
Last Update Posted: May 4, 2016
Last Verified: March 2016
Keywords provided by Ji Eun Lee, Pusan National University Hospital:
age-related macular degeneration
choroidal neovascularization
ranibizumab
indocyanine angiography
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents