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

Condition(s) targeted: Type 2 Idiopathic Macular Telangiectasia

Intervention: Intravitreal injection ranibizumab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Bonn

Official(s) and/or principal investigator(s):
Frank Holz, MD, Principal Investigator, Affiliation: University of Bonn, Department of Ophthalmology
Hendrik PN Scholl, MD, MA, Principal Investigator, Affiliation: University Hospital, Bonn

Overall contact:
Zentrum für klinische Studien, Phone: +49 / 228 2871 4748

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.

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 design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Best corrected visual acuity

Secondary outcome:

Reading ability

Scotomas measured by means of microperimetry

Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging

Changes in parafoeal leakage assessed by fluorescein angiography

Quality of life

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 disesase such as diabetic retinopathy or venous

occlusive diseases

- ocular surgery 3 months before study enrolement

- 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 enrolement

- history of severe cardiovascular disease or history of stroke 6 months before study

enrolement

- 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

Zentrum für klinische Studien, Phone: +49 / 228 2871 4748

Department of Ophthalmology, University of Bonn, Bonn, Germany; Recruiting
Frank G. Holz, MD, Phone: +49 / 228 2871 5647, Email: Frank.Holz@ukb.uni-bonn.de
Hendrik PN Scholl, MD, MA, Phone: +49 / 228 2871 5505, Email: Hendrik.Scholl@ukb.uni-bonn.de
Frank G. Holz, MD, Principal Investigator
Peter Charbel Issa, MD, Sub-Investigator
Hendrik PN Scholl, MD, MA, Principal Investigator

Starting date: August 2007
Ending date: October 2008
Last updated: September 14, 2007