Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration

Conditions
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Exudative Age-related Macular Degeneration

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >= 50 Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area. Area of CNV clearly visible in ICGA is more than half of the total CNV area. Exclusion Criteria: CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc) Blocked fluorescence in ICGA is more than half of the total CNV area. Disciform scar Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months Previous any treatment of photodynamic therapy or photocoagulation Previous intraocular or periocular injection of steroid within 3 months Previous intraocular surgery except cataract surgery Vitreo-retinal interface disease on the macula Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.) Uncontrolled periocular or intraocular infection History of hypersensitivity to ranibizumab treatment Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab<br>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<br>* 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.<br>* Other names: intravitreal injection of ranibizumab (Lucentis, Novartis);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caliber of Choroidal New Vessel (CNV) | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Size of CNV | Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels. | 6 months | 
| Visual Acuity in ETDRS Letters | 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. | 6 months | 
| Visual Acuity Changes | 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. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age-related macular degeneration, choroidal neovascularization, ranibizumab, indocyanine angiography