Effect of Intravitreal Ranibizumab on Radiation Retinopathy Following Plaque Brachytherapy for Choroidal Melanoma

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

Sponsor
The New York Eye Cancer Center
Study ID
NCT00750399
Phase
PHASE1
Status
Completed

Conditions

  • Choroidal Melanoma
  • Radiation Retinopathy

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    intravitreal ranibizumab monthly for 4 months, and then every month thereafter until month 12.
  • ranibizumab — DRUG
    intravitreal ranibizumab 0.5 mg

Study Details

This is a Phase I clinical trial to test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy following plaque brachytherapy for patients with choroidal melanoma using the incidence and severity of events criteria. The secondary objective is to assess the efficacy of intravitreal ranibizumab on regression of radiation retinopathy by ophthalmic examination, fundus photography, fluorescein angiography, and optical coherence tomography, as well as visual acuity.

Key Dates

First listed
Sep 10, 2008
Start date
Oct 31, 2008
Status verified
Apr 2012
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

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

Arms

  • Experimental: Intravitreal ranibizumab
    Patients will receive intravitreal ranibizumab on a monthly basis depending on response to treatment

Primary Outcome Measure

To test the safety and tolerability of intravitreal ranibizumab in the treatment of radiation retinopathy associated with plaque brachytherapy for choroidal melanoma [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The New York Eye Cancer CenterNew YorkNew York10065-

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The New York Eye Cancer Center· New York, NY

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