Ranibizumab in idiopathic macular telangiectasia, type2 A prospective interventional non-randomized study comparing the efficacy and safety of intravitreal ranibizumab (dosing regimen 0.5mg every month over a period of one year) in type 2 idiopathic macular telangiectasia[Intravitreales Ranibizumab zur Therapie von idiopathischen makulären Teleangiektasien, Typ 2]
- Conditions
- Typical findings in Type 2 idiopathic macular telangiectasia (type2-IMT)are parafoveal ectatic capillaries, The disease is characterized by a slow decrease in visual acuity, reading difficulties and/or metamorphopsia starting in the fifth to seventh decade. Both atrophy and secondary choroidal neovascularisation may occur with disease progression. So far there has been no therapy with proven benefit for type2-IMT.MedDRA version: 9.1Level: LLTClassification code 10064761Term: Parafoveal telangiectasia
- Registration Number
- EUCTR2006-006233-40-DE
- Lead Sponsor
- Department of Ophthalmology, Bonn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
•Age >18 years
•Written Informed Consent has been obtained.
•Best corrected visual acuity in the study eye: 20/200 - 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients with other retinal vascular diseases. such as Diabetic Retinopathy or retinal vascular occlusion
•Previous intravitreal Injection of antiangiogenetic drugs into the study eye within the last 6 months.
•Any surgery in the study eye within the last 3 months prior to inclusion into the study.
•History of an uncontrolled glaucoma in the study eye
•active inflammation in the study eye or the acular adnexa
•Subfoveal fibrosis in the study eye
•Inability to comply with the study protocol
•Major general surgery one month prior to inclusion into the study
•Known allergy to humanized antibodies
•Pregnancy or insufficient contraception
•History of serious cardio-vascular problems or stroke 6 months prior to inclusion into the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective: <br>Improvement of best corrected visual acuity from baseline to 12 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters<br>;Secondary Objective: Secondary Objectives: <br>1.Assessment of changes on digital fundus photography<br>2.Quantitative and qualitative assessment of changes in Optical Coherence Topography (OCT)<br>3.Qualitative assessment of changes in fluorescein angiography<br>4.Registration of complications related to drug or its administration<br>;Primary end point(s): Improvement of best corrected visual acuity from baseline to 12 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters
- Secondary Outcome Measures
Name Time Method