Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
Primary Purpose
Type 2 Idiopathic Macular Telangiectasia
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Intravitreal injection ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Idiopathic Macular Telangiectasia focused on measuring macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, 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
Sites / Locations
- Department of Ophthalmology, University of Bonn
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Best corrected visual acuity
Secondary Outcome Measures
Reading ability
Scotomas measured by means of microperimetry
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Changes in parafoveal leakage assessed by fluorescein angiography
Quality of life
Full Information
NCT ID
NCT00504400
First Posted
July 18, 2007
Last Updated
September 21, 2009
Sponsor
University Hospital, Bonn
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00504400
Brief Title
Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Bonn
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Idiopathic Macular Telangiectasia
Keywords
macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, lucentis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
one year
Secondary Outcome Measure Information:
Title
Reading ability
Time Frame
one year
Title
Scotomas measured by means of microperimetry
Time Frame
one year
Title
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Time Frame
one year
Title
Changes in parafoveal leakage assessed by fluorescein angiography
Time Frame
one year
Title
Quality of life
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Holz, MD
Organizational Affiliation
University of Bonn, Department of Ophthalmology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik PN Scholl, MD, MA
Organizational Affiliation
University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, University of Bonn
City
Bonn
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
21334595
Citation
Charbel Issa P, Finger RP, Kruse K, Baumuller S, Scholl HP, Holz FG. Monthly ranibizumab for nonproliferative macular telangiectasia type 2: a 12-month prospective study. Am J Ophthalmol. 2011 May;151(5):876-886.e1. doi: 10.1016/j.ajo.2010.11.019. Epub 2011 Feb 19. Erratum In: Am J Ophthalmol. 2011 Jul;152(1):151.
Results Reference
derived
PubMed Identifier
20877651
Citation
Charbel Issa P, Troeger E, Finger R, Holz FG, Wilke R, Scholl HP. Structure-function correlation of the human central retina. PLoS One. 2010 Sep 22;5(9):e12864. doi: 10.1371/journal.pone.0012864.
Results Reference
derived
Links:
URL
http://www.augenklinik.uni-bonn.de
Description
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Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
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