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.

Sponsors

Lead Sponsor: University Hospital, Bonn

Collaborator: Novartis

Source University Hospital, Bonn
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.

Overall Status Completed
Start Date August 2007
Completion Date September 2009
Primary Completion Date June 2009
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Best corrected visual acuity one year
Secondary Outcome
Measure Time Frame
Reading ability one year
Scotomas measured by means of microperimetry one year
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging one year
Changes in parafoveal leakage assessed by fluorescein angiography one year
Quality of life one year
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: Intravitreal injection ranibizumab

Description: Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year

Arm Group Label: A

Other Name: Lucentis

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

- 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Department of Ophthalmology, University of Bonn
Location Countries

Germany

Verification Date

September 2009

Responsible Party

Name Title: University of Bonn

Organization: University of Bonn

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: A

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov