Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Bonn, Germany
- Department of Ophthalmology, University of Bonn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: A
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Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Best corrected visual acuity
Time Frame: one year
|
one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: one year
|
one year
|
|
Reading ability
Time Frame: one year
|
one year
|
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Scotomas measured by means of microperimetry
Time Frame: one year
|
one year
|
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Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Time Frame: one year
|
one year
|
|
Changes in parafoveal leakage assessed by fluorescein angiography
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Holz, MD, University of Bonn, Department of Ophthalmology
- Principal Investigator: Hendrik PN Scholl, MD, MA, University of Bonn
Publications and helpful links
General Publications
- Charbel Issa P, Finger RP, Kruse K, Baumuller S, Scholl HP, Holz FG. Monthly ranibizumab for nonproliferative macular telangiectasia type 2: a 12-month prospective study. Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19. Erratum In: Am J Ophthalmol. 2011 Jul;152(1):151.
- Charbel Issa P, Troeger E, Finger R, Holz FG, Wilke R, Scholl HP. Structure-function correlation of the human central retina. PLoS One. 2010 Sep 22;5(9):e12864. doi: 10.1371/journal.pone.0012864.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRFB002ADE04
- EudraCT number 2006-006233-40
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