Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403325
• Other study ID #: FVF3850S
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2006
• Last updated: October 31, 2008
• Start date: August 2006

Study information

• Verified date: October 2008
• Source: Vitreous -Retina- Macula Consultants of New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.

Description:

This is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with unresolving CSC and subfoveal fluid. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 days (± 2 days) for 3 injections. Thereafter they are to be evaluated every month until month 12. Treatment will be administered to patients if there is presence of active leakage as determined by fluorescein angiography or persistence presence of sub retinal fluid upon OCT examination at that monthly visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A history of persistent central serous chorioretinopathy present for at least 3 months Best-corrected visual acuity (BCVA) of 20/40 (73 letters on the ETDRS chart) to light perception as measured by ETDRS protocol refraction.

• No signs of choroidal neovascularization

• Documented subfoveal fluid by OCT

• Active leak associated with the subfoveal fluid

• The ability and willingness to provide written informed consent

Exclusion Criteria:

• Prior treatment with laser or PDT

• Have uncontrolled hypertension

• Have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction

• Have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day.

• Are receiving or require chronic concomitant therapy with systemic (> 5 mg) or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening

• Previously vitrectomized eyes.

• Had allergic reactions to fluorescein dye or lack of venous access.

• Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.

• An anticipated need for ocular surgery during the duration of the trial.

• Within 1 month prior to screening, have had intra ocular surgeries (including cataract surgery) in the study eye.

• Intravitreal triamcinolone or bevacizumab in the previous 2 months

• Uncontrolled glaucoma (IOP > 24 mmHg) on greater than 3 medications.

• Within 1 month prior to screening had YAG laser capsulotomy in the study eye

• Have received any other systemic experimental drug within 12 weeks prior to enrollment.

• Rubeosis iridis or neovascular glaucoma

• Any untreated rhegmatogenous retinal detachment.

• A visual acuity of worse than 20/400 in the fellow eye.

• Unwilling or unable to follow or comply with all study related procedures.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• rhuFab V2 [ranibizumab] ( Lucentis )

Locations

Country	Name	City	State
United States	Vitreous Retina Macula Consultants of New York, P.C.	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Vitreous -Retina- Macula Consultants of New York	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)
Secondary	Mean change in VA compared to baseline at month 6 and month 12
Secondary	Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Secondary	Proportion of patients losing = 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Secondary	Proportion of patients gaining = 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Secondary	Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12