Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)

Type 2 Idiopathic Macular Telangiectasia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504400
• Other study ID #: CRFB002ADE04
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2007
• Last updated: September 21, 2009
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Telangiectasis
• Type 2 Idiopathic Macular Telangiectasia

Intervention

Drug:
• Intravitreal injection ranibizumab
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year

Locations

Country	Name	City	State
Germany	Department of Ophthalmology, University of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		one year	No
Secondary	Reading ability		one year	No
Secondary	Scotomas measured by means of microperimetry		one year	No
Secondary	Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging		one year	No
Secondary	Changes in parafoveal leakage assessed by fluorescein angiography		one year	No
Secondary	Quality of life		one year	No

External Links

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