A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration
Overview
- Phase
- Phase 4
- Intervention
- ranibizumab
- Conditions
- Exudative Age-related Macular Degeneration
- Sponsor
- Pusan National University Hospital
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Caliber of Choroidal New Vessel (CNV)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Ji Eun Lee
Associate professor
Pusan National University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: ranibizumab
Outcomes
Primary Outcomes
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 Outcomes
- Visual Acuity Changes(baseline and 6 months)
- Lesion Size of CNV(6 months)
- Visual Acuity in ETDRS Letters(6 months)