High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy

Phase 1

Completed

• Conditions: Radiation Retinopathy
• Interventions: Drug: ranibizumab 2.0 mg

• Registration Number: NCT01334879
• Lead Sponsor: The New York Eye Cancer Center

Brief Summary

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.

Detailed Description

This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.

Study Timeline

• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Study Start: 2011-05
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Loading Doses	ranibizumab 2.0 mg	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)
Physician Discretion	ranibizumab 2.0 mg	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 Measures

Name	Time	Method
Number of participants with adverse events (allergy, infection, or change in vital signs)	Baseline, at day 7, then monthly	All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs

Secondary Outcome Measures

Name	Time	Method
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography	Monthly Report at Month 12	Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.
Number of participants with changes in central foveal thickness	Monthly, Report at Month 12	This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Number of participants with changes in visual acuity	Monthly, Report at Month 12	Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Number of injections each group (arm) has received	Monthly, Report at Month 12	Each group (arm) will be assessed for the number of monthyl injections received through Month 12.

Trial Locations

Locations (1)

The New York Eye Cancer Center; 🇺🇸 New York, New York, United States