Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy - Full Text View

Purpose

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

Condition	Intervention	Phase
Central Serous Chorioretinopathy	Drug: rhuFab V2 [ranibizumab] ( Lucentis )	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.

Resource links provided by NLM:

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Vitreous -Retina- Macula Consultants of New York:

Primary Outcome Measures:

To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)

Secondary Outcome Measures:

Mean change in VA compared to baseline at month 6 and month 12
Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12

Enrollment:	9
Study Start Date:	August 2006

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403325

Locations

United States, New York
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, United States, 10022

Sponsors and Collaborators

Vitreous -Retina- Macula Consultants of New York

Genentech

Investigators

Principal Investigator:

Richard F. Spaide, M.D.

Vitreous Retina Macula Consultants of New York, P.C.

More Information

No publications provided

Responsible Party:	Richard Spaide, MD / Principal Investigator, Vitreous Retina Macula Consultants of New York
ClinicalTrials.gov Identifier:	NCT00403325 History of Changes
Other Study ID Numbers:	FVF3850S
Study First Received:	November 22, 2006
Last Updated:	October 31, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vitreous -Retina- Macula Consultants of New York:

Central Serous Chorioretinopathy

Additional relevant MeSH terms:

Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013