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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

NCT01846299

Macular Edema (ME)

COMPLETED PHASE3

Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation

NCT00457145

Telangiectasia

COMPLETED PHASE1

Development of Intravitreal Ranibizumab by Determining the Pathogenesis of Macular Edema With Retinal Vein Occlusion

NCT02169648

Macular Edema Branch Retinal Vein Occlusion Central Retinal Vein Occlusion

UNKNOWN NA

Injected Ranibizumab to Treat Macular Telangiectasia With New Blood Vessel Formation

NCT00457067

Telangiectasia

COMPLETED PHASE1

Ranibizumab Injections to Treat Macular Telangiectasia Without New Blood Vessel Growth

NCT00685854

Macular Telangiectasia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Idiopathic Macular Telangiectasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

Intravitreal injection ranibizumab

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal injection ranibizumab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No