Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy

Part of paid clinical trials in New York, New York.

Sponsor
Manhattan Eye, Ear & Throat Hospital
Study ID
NCT00470977
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • BEST VITELLIFORM MACULAR DYSTROPHY, MULTIFOCAL (Disorder)
  • Coats' Disease
  • Idiopathic Retinal Telangiectasia
  • Multi-focal Choroiditis
  • Pathological Myopia
  • Polypoidal Choroidal Vasculopathy
  • Pseudoxanthoma Elasticum
  • Retinal Angiomatous Proliferation
  • Rubeosis Iridis
  • Von Hippel Lindau Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab injection (0.5 mg) — DRUG
    ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.

Study Details

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.

Key Dates

First listed
May 8, 2007
Start date
May 31, 2007
Status verified
Oct 2012
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: (Ranibizumab) Lucentis
    (Ranibizumab)Lucentis 0.5%

Primary Outcome Measure

Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions [ Time Frame: 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lenox Hill Hospital/Manhattan Eye Ear and Throat InstituteNew YorkNew York10065-
Lenox Hill Hospital/Manhattan Eye, Ear & Throat InstituteNew YorkNew York10065-

Find similar trials in New York, NY

By research site
Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute· New York, NYLenox Hill Hospital/Manhattan Eye, Ear & Throat Institute· New York, NY

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