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| Sponsor: | Manhattan Eye, Ear & Throat Hospital |
|---|---|
| Collaborator: |
Genentech |
| Information provided by: | Manhattan Eye, Ear & Throat Hospital |
| ClinicalTrials.gov Identifier: | NCT00470977 |
Purpose
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 conditions (Coats’ disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence and severity of adverse events.
Limited forms of treatment are available that limit the loss of visual acuity. However, the patients may not have any substantial improvement in acuity or function. Therefore there remains a significant unmet need for therapeutic options managing the neovascularization and its consequences.
Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD conditions.
The rationale for the study design is as follows:
| Condition | Intervention | Phase |
|---|---|---|
|
Coats’ Disease Idiopathic Perifoveal Telangiectasia Retinal Angiomatous Proliferation Polypoidal Vasculopathy Pseudoxanthoma Elasticum Pathological Myopia Multi-Focal Choroiditis Rubeosis Iridis |
Drug: ranibizumab injection (0.5 mg) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy (Coats’ Disease, Idiopathic Perifoveal Telangiectasia, Retinal Angiomatous Proliferation, Polypoidal Vasculopathy, Pseudoxanthoma Elasticum, Pathological Myopia, Multi-Focal Choroiditis, Rubeosis Iridis) With Intravitreal Injection of Lucentis (Ranibizumab Injection) |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2008 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Contacts and Locations| Contact: Leandro C. Maranan | 212-605-3777 | lmaranan@retinal-research.org |
| Contact: Joan Daly, RN | 212-605-3777 | jdaly@retinal-research.org |
| United States, New York | |
| Vitreous-Retina-Macula Consultants of New York | Recruiting |
| New York, New York, United States, 10022 | |
| Contact: Leandro C. Maranan 212-605-3777 lmaranan@retinal-research.org | |
| Contact: Joan C. Daly, RN 212-605-3777 jdaly@retinal-research.org | |
| Principal Investigator: Lawrence A. Yannuzzi, MD | |
| Sub-Investigator: Michael Cooney, MD,M.B.A. | |
| Sub-Investigator: K.Bailey Freund, MD | |
| Sub-Investigator: John A. Sorenson, MD | |
| Sub-Investigator: Jason S. Slakter, MD | |
| Sub-Investigator: Richard F. Spaide, MD | |
| Sub-Investigator: James M. Klancnik,Jr., MD | |
| Sub-Investigator: Lucian V. Del Priore, MD,PhD. | |
| Sub-Investigator: Belinda L. Shirkey, MD | |
| Manhattan Eye, Ear & Throat Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Leandro C. Maranan 212-605-3777 lmaranan@retinal-research.org | |
| Contact: Joan Daly, RN 212-605-3777 jdaly@retinal-research.org | |
| Principal Investigator: Lawrence A. Yannuzzi, MD | |
| Principal Investigator: | Lawrence A. Yannuzzi, MD | LuEsther T. Mertz Retinal Research Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00470977 History of Changes |
| Other Study ID Numbers: | Protocol: FVF4140S |
| Study First Received: | May 4, 2007 |
| Last Updated: | July 18, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Choroiditis Macular Degeneration Myopia Pseudoxanthoma Elasticum Telangiectasis Myopia, Degenerative Retinal Telangiectasis Choroid Diseases Uveal Diseases Eye Diseases Uveitis, Posterior Panuveitis Uveitis Retinal Degeneration |
Retinal Diseases Refractive Errors Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders Hematologic Diseases Skin Abnormalities Congenital Abnormalities Skin Diseases, Genetic Genetic Diseases, Inborn Connective Tissue Diseases Skin Diseases |