Type 2 Idiopathic Macular TelangiectasiaPhase 2NCT00504400
Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial)
A Phase 2 study testing Intravitreal injection ranibizumab in people with Type 2 Idiopathic Macular Telangiectasia, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Idiopathic Macular Telangiectasia
- What is being tested?
- Intravitreal injection ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Type 2 Idiopathic Macular Telangiectasia
- Being tested
- Intravitreal injection ranibizumab
- Keywords
- macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection ranibizumabDrug
Also called Lucentis
Monthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Intravitreal injection ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: one year
Secondary outcomes (5)
Reading ability
Measured: one year
Scotomas measured by means of microperimetry
Measured: one year
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Measured: one year
Changes in parafoveal leakage assessed by fluorescein angiography
Measured: one year
Quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Idiopathic Macular TelangiectasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Frank Holz, MD, Principal investigator, University of Bonn, Department of OphthalmologyHendrik PN Scholl, MD, MA, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504400
- Sponsor's protocol ID
- CRFB002ADE04
- Other IDs
- EudraCT number 2006-006233-40
- Status last verified
- Sep 2009
- First submitted
- 18 Jul 2007
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21334595Charbel 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.
PubMed 20877651
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00504400
- Acronym / sponsor ID
- CRFB002ADE04
- Conditions
- Type 2 Idiopathic Macular Telangiectasia
- Keywords
- macular telangiectasia, parafoveal telangiectasis, nonproliferative, therapy, intravitreal injection, ranibizumab, lucentis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Intravitreal injection ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal injection ranibizumabAlso: LucentisMonthly intravitreal injection of of 0.5mg ranibizumab in one eye over one year | Drug | A |
Primary outcome
Best corrected visual acuity
Time frame: one year
5 secondary outcomes
Reading ability
Time frame: one year
Scotomas measured by means of microperimetry
Time frame: one year
Changes in retinal thickness assessed by optical coherence tomography (OCT) imaging
Time frame: one year
Changes in parafoveal leakage assessed by fluorescein angiography
Time frame: one year
Quality of life
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
- Derived from this study: PubMed 21334595Charbel 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.
- Derived from this study: PubMed 20877651Charbel 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Holz, MD principal investigator
University of Bonn, Department of Ophthalmology
Hendrik PN Scholl, MD, MA principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal injection ranibizumab in people with Type 2 Idiopathic Macular Telangiectasia, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.