Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy

Southeast Retina Center, Georgia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00837330

FVF3761s

Details and patient eligibility

About

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.

Full description

Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (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. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).

Enrollment: 20 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Ranibizumab 0.5 mg/ 0.05 cc

Experimental group

Description:

Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab

Treatment:

Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc

Ranibizumab 0.3 mg/ 0.05 cc

Experimental group

Description:

Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab

Treatment:

Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc