Investigation of Radiation Retinopathy (RadiRet Study)

Phase 1

• Conditions: Patients with retinopathy, due to irradiation in uveal melanoma; MedDRA version: 14.1Level: PTClassification code 10064714Term: Radiation retinopathySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-004463-69-DE
• Lead Sponsor: Charité – University Medicine Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Clinical signs of radiation retinopathy (cotton wool spots, hemorrhages, vascular ischemia)
•Visual impairment due to focal or diffuse radiation induced ME in the irradiated eye that is eligible for laser treatment
•Age =18 years
•BCVA less than 20/32

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent VA improvement, e.g. tumor recurrence, tumor growth underneath the macula
•Endoresection and / or previous vitrectomy
•Patients with proliferative retinopathies or macular edema due to reasons other than irradiation: e.g. diabetic retinopathy, vein occlusion, or Irvine-Gass syndrome
•Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation
•Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate superiority of ranibizumab 0.5 mg to laser treatment regarding change from baseline in BCVA over a 6-month treatment period;Secondary Objective: Secondary endpoints:<br>•Change from baseline in macular thickness and the size of areas of macular and peripheral capillary drop out over 6 months (area under the curve / 6 months)<br>•Change from baseline in BCVA, macular thickness and the size of areas of macular and peripheral capillary drop out over 12 months (area under the curve / 12 months)<br>•Proportion of patients with improvement of visual acuity after 6 and 12 months<br>•Rate of vitreous hemorrhages<br>;Primary end point(s): Change from baseline in BCVA over 6 months (area under curve / 6 months);Timepoint(s) of evaluation of this end point: change after 6 months from baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change from baseline in macular thickness and the size of areas of macular and peripheral capillary drop out over 6 months (area under the curve / 6 months)<br>•Change from baseline in BCVA, macular thickness and the size of areas of macular and peripheral capillary drop out over 12 months (area under the curve / 12 months)<br>•Proportion of patients with improvement of visual acuity after 6 and 12 months<br>•Rate of vitreous hemorrhages<br>;Timepoint(s) of evaluation of this end point: change after 6 and 12 months from baseline