Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy (FVF4140S)
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|ClinicalTrials.gov Identifier: NCT00470977|
Recruitment Status : Completed
First Posted : May 8, 2007
Last Update Posted : October 25, 2012
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:
A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food and Drug Administration (FDA) approved and labeled for intravitreal injection use for neovascular (wet) age-related macular degeneration will be used.
In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF) plays a role in the pathogenesis as in neovascular AMD.
Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on considerations of the half-life and the clinical response in patients with neovascularization suggests that a 1-month interval is optimal.
|Condition or disease||Intervention/treatment||Phase|
|Coats' Disease Idiopathic Retinal Telangiectasia Retinal Angiomatous Proliferation Polypoidal Choroidal Vasculopathy Pseudoxanthoma Elasticum Pathological Myopia Multi-focal Choroiditis Rubeosis Iridis Von Hippel Lindau Disease BEST VITELLIFORM MACULAR DYSTROPHY, MULTIFOCAL (Disorder)||Drug: ranibizumab injection (0.5 mg)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy With Intravitreal Injection of Lucentis (Ranibizumab Injection)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: (Ranibizumab) Lucentis
Drug: ranibizumab injection (0.5 mg)
ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
Other Name: Lucentis
- Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions [ Time Frame: 24 months ]
- Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline [ Time Frame: 24 months ]
- Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline [ Time Frame: 24 months ]
- Number of additional injections required following the initial 3 injections [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470977
|United States, New York|
|Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute|
|New York, New York, United States, 10065|
|Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute|
|New York, New York, United States, 10065|
|Principal Investigator:||Lawrence A. Yannuzzi, MD||LuEsther T. Mertz Retinal Research Center|