Ranibizumab in Idiopathic Macular Telangiectasia, Type 2. A Prospective Interventional Non-randomized Study Comparing the Efficacy and Safety of Intravitreal Ranibizumab in Type 2 Idiopathic Macular Telangiectasia.
Overview
- Phase
- Phase 2
- Intervention
- Intravitreal injection ranibizumab
- Conditions
- Type 2 Idiopathic Macular Telangiectasia
- Sponsor
- University Hospital, Bonn
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Best corrected visual acuity
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Detailed Description
Type 2 idiopathic macular telangiectasia (type 2 IMT) is a retinal disease of unknown etiology that commonly presents with a slow decrease in visual acuity, reading difficulties and metamorphopsia in the fifth to seventh decade. Diagnosis is based on fluorescein angiography which typically reveals parafoveal leakage in the late phase and may show telangiectatic capillaries in the early phase. In a subset of patients, a proliferative stage with secondary neovascularizations may develop late in the disease course. In the past, there has been no effective treatment for the disease stages without neovascularization. Recent studies in a limited number of patients with nonproliferative disease have shown promising results after intravitreal injection of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF). Bevacizumab resulted in a decrease of parafoveal leakage in fluorescein angiography and a decrease in retinal thickness. An increase in visual acuity was reported in a subset of patients. The RAMA-Trial is initiated in order to investigate the effect of a ranibizumab. The safety and tolerability of this VEGF-antagonist has been extensively studied in large cohorts of patients suffering from age-related macular degeneration. Patients with type 2 IMT will receive monthly injections over a period of one year. The above mentioned outcome measures will be assessed.
Investigators
Eligibility 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
Arms & Interventions
A
Intervention: Intravitreal injection ranibizumab
Outcomes
Primary Outcomes
Best corrected visual acuity
Time Frame: one year
Secondary Outcomes
- Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging(one year)
- Quality of life(one year)
- Changes in parafoveal leakage assessed by fluorescein angiography(one year)
- Reading ability(one year)
- Scotomas measured by means of microperimetry(one year)