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: 9.1 Level: LLT Classification code 10064761 Term: Parafoveal tel
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ranibizumab
Current Sponsor code: CRFB002ADE04
Other descriptive name:
Sponsors
Department of Ophthalmology, Bonn University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: 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 Objective: Secondary Objectives: 1. Assessment of changes on digital fundus photography 2. Quantitative and qualitative assessment of changes in Optical Coherence Topography (OCT) 3. Qualitative assessment of changes in fluorescein angiography 4. Registration of complications related to drug or its administration ;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 | — |
Countries
Germany
Outcome results
None listed