Phase 2
N=20
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Polypoidal Choroidal Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT00837330 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Commonly Reported and Notable Adverse Events — 1; 2; 2; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ranibizumab 0.5 or 0.3 mg/0.05 cc (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Southeast Retina Center, Georgia
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Commonly Reported and Notable Adverse Events |
1; 2; 2; 3; 1; 2 | — |
Summary
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Eligibility Criteria
Inclusion Criteria
- Age >35 years
- Exudative, active PCV in 1 eye.
- PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.
Exclusion Criteria
- Age <35 years
- Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
Data sourced from ClinicalTrials.gov (NCT00837330). 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.