Phase 4
N=49
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
Exudative Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01810042 ↗Enrolled (actual)
49
Serious AEs
4.1%
Results posted
Apr 2014
Primary outcome: Primary: Caliber of Choroidal New Vessel (CNV) — 43.53 micrometer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ranibizumab (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pusan National University Hospital
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caliber of Choroidal New Vessel (CNV) |
43.53 | — |
| SECONDARY Lesion Size of CNV |
3.03 | — |
| SECONDARY Visual Acuity in ETDRS Letters |
69 | — |
| SECONDARY Visual Acuity Changes |
12.5 | — |
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.
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT01810042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.