Clinical trial NCT00403325: Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy
Official title: Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Serous Chorioretinopathy
Keywords: Central Serous Chorioretinopathy
Lead sponsor: Vitreous -Retina- Macula Consultants of New York
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-11-23
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)
Secondary outcomes:
measure: Mean change in VA compared to baseline at month 6 and month 12
measure: Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
measure: Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
measure: Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
measure: Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York, P.C.
state: New York
Study officials:
affiliation: Vitreous Retina Macula Consultants of New York, P.C.
name: Richard F. Spaide, M.D.
role: PRINCIPAL_INVESTIGATOR
References: