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

Sponsor

University Hospital, Bonn (Other)

Overall Status

Completed

CT.gov ID

NCT00504400

Collaborator

Novartis (Industry)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Idiopathic Macular Telangiectasia	Drug: Intravitreal injection ranibizumab	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: Intravitreal injection ranibizumab Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year Other Names: Lucentis

Arm

Intervention/Treatment

Experimental: A

Drug: Intravitreal injection ranibizumab

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

Other Names:

Lucentis

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity [one year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, University of Bonn	Bonn		Germany

Sponsors and Collaborators

University Hospital, Bonn
Novartis

Investigators

Principal Investigator: Frank Holz, MD, University of Bonn, Department of Ophthalmology
Principal Investigator: Hendrik PN Scholl, MD, MA, University of Bonn