Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate if a new drug called ranibizumab is effective to treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type 2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of one year.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bonn
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• diagnosis of type 2 idiopathic macular telangiectasia

• minimum of 18 years

• patient must be able to follow protocol

• written informed consent

• best corrected visual acuity between 20/200 - 20/32 in the treated eye

Exclusion Criteria:

• patients who do not fulfill the inclusion criteria

• patients with other retinal vascular disease such as diabetic retinopathy or venous occlusive diseases

• ocular surgery 3 months before study enrollment

• history of uncontrolled glaucoma

• active intraocular inflammation or inflammation of the ocular adnexa

• subfoveal fibrosis in the study eye

• inability to follow study protocol

• major surgery one month before study enrollment

• history of severe cardiovascular disease or history of stroke 6 months before study enrollment

• allergies against substances or components of the study medication

• low anticipated compliance

• patients who participate(d) in clinical trials simultaneously or within the last 60 days

• pregnancy, lactation, women that may become pregnant and don't use safe contraception

• chronic alcohol- or drug abuse within the last year

• lacking legal competence or language ability

• neurologic diseases such as multiple sclerosis

• need of concomitant medication that is not allowed in combination with ranibizumab

• previous intravitreal therapy with anti-angiogenic substances in the study eye within the last 6 months