High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

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

Sponsor
The New York Eye Cancer Center
Study ID
NCT01334879
Phase
PHASE1
Status
Completed

Conditions

  • Radiation Retinopathy

Eligibility Criteria

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

Interventions

Study Details

This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.

Key Dates

First listed
Apr 13, 2011
Start date
May 31, 2011
Status verified
Sep 2014
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
10 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: With Loading Doses
    5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections)
  • Active Comparator: Physician Discretion
    5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study.

Primary Outcome Measure

Number of participants with adverse events (allergy, infection, or change in vital signs) [ Time Frame: Baseline, at day 7, then monthly ]

Locations (1)

FacilityCityStateZIPSite coordinators
The New York Eye Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By research site
The New York Eye Cancer Center· New York, NY

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