Investigation of Radiation Retinopathy (Radi-Ret Study)Subtitle: Influence of Lucentis® on radiation retinopathy after irradiation of choroidal melanoma

Phase 2

• Conditions: H35.8; Other specified retinal disorders

• Registration Number: DRKS00003246
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Study Completion: 2016-12-02
• Results First Posted: 2020-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Clinical signs of radiation retinopathy (cotton wool spots, hemorrhages, vascular ischemia)

Visual impairment due to focal or diffuse radiation induced macula edema (ME) in the irradiated eye that is eligible for laser treatment

Age =18 years

BCVA less than 20/32

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

Known hypersensitivity against local anaesthetics

Known hypersensitivity against iodine

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in BCVA (Best Corrected Visual Acuity) over 6 months (area under curve / 6 months)

Secondary Outcome Measures

Name	Time	Method
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><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><br>Proportion of patients with improvement of visual acuity after 6 and 12 months<br><br>Rate of vitreous hemorrhages