Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Pusan National University

Status and phase: Completed; Phase 4

Conditions: Exudative Age-related Macular Degeneration

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01810042

임상20120178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

ranibizumab

Experimental group

Description:

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.

Treatment:

Drug: ranibizumab