Status:
COMPLETED
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Coats' Disease
Idiopathic Retinal Telangiectasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of intravitreal injections of ranibizumab in the treatment of AMD variants and other choroidal neovascularization (CNV) related con...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Clinical diagnosis of the following conditions: Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis.
- Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart.
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy is initiated
- Participation in another simultaneous medical investigation or trial
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within the last 2 months.
- Patient participating in any other investigational drug study.
- Use of an investigational drug or treatment related or unrelated to the patient's condition within 30 days prior to receipt of study medication (verteporfin, pegaptanib, or other AMD therapy in the study eye)
- Patient treated with systemic anti-VEGF or pro-VEGF agents within 3 months before enrollment.
- Previous treatment (in either eye) with intravitreal or intravenously administered Avastin (bevacizumab).
- Inability to obtain photographs to document CNV (including difficulty with venous access).
- Patient with a known adverse reaction to fluorescein dye.
- Patient has a history of any medical condition which would preclude scheduled visits or completion of the study.
- Patient has had insertion of scleral buckle in the study eye
- Patient has received radiation treatment.
- Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation.
- Pregnancy (positive pregnancy test) or lactation.
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
- History of glaucoma filtering surgery in the study eye.
- Concurrent use of more than two therapies for glaucoma.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure \> 30 mm Hg despite treatment with anti-glaucoma medication)
- Inability to comply with study or follow-up procedure
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00470977
Start Date
May 1 2007
End Date
December 1 2010
Last Update
October 25 2012
Active Locations (2)
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1
Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute
New York, New York, United States, 10065
2
Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute
New York, New York, United States, 10065