Investigation of Radiation Retinopathy (RadiRet Study)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004463-69-DE

Enrollment

Registered

2012-08-03

Start date

2012-12-11

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with retinopathy, due to irradiation in uveal melanoma MedDRA version: 14.1 Level: PT Classification code 10064714 Term: Radiation retinopathy System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Ranibizumab (Lucentis®) Product Name: Lucentis Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: • 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) • 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) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages ;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	—

Measure

Time frame

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: • 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) • 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) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages ;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

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Secondary

Measure	Time frame
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) • 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) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages ;Timepoint(s) of evaluation of this end point: change after 6 and 12 months from baseline	—

Measure

Time frame

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) • 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) • Proportion of patients with improvement of visual acuity after 6 and 12 months • Rate of vitreous hemorrhages ;Timepoint(s) of evaluation of this end point: change after 6 and 12 months from baseline

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Countries

Germany

Contacts

Public ContactProf. Dr. med. Antonia M. Joussen (

Charité University Medicine Berlin

joussena@gmail.com0049308445 2331

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026