TelangiectasiaPhase 1NCT00457145
Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation
A Phase 1 study testing Ranibizumab in people with Telangiectasia, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Telangiectasia
- What is being tested?
- Ranibizumab
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2007to 24 Oct 2007
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must understand and sign the informed consent.
- Participant must be at least 18 years of age.
- Participant must have macular telangiectasia in both eyes.
- Participant must have vision loss of 20/40 or worse.
- Participant must have clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography.
- All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo testing immediately prior to each injection and monthly for at least 2 months following the last dose of ranibizumab.
- Women of child-bearing potential who are sexually active and men who are sexually active are required to use two forms of birth control during the course of the study.
Who cannot join
- Participant has neovascularization in either eye.
- History (within past 5 years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
- History of stroke within 12 months of study entry.
- History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
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- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
- History of vitrectomy surgery in the study eye.
- History of glaucoma filtering surgery in the study eye.
- History of corneal transplant in the study eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia Without Neovascularization
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where new vessel formation under the retina is absent.
Patients 18 years of age and older who have macular telangiectasia without new blood vessel formation may be eligible for this study. Visual acuity must be 20/40 or worse.
Read more
Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures:
- Medical history and physical examination.
- Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye.
- Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina.
- Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.
- Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light.
- Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.
- Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture.
- Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.
Read the detailed description
Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the former group 2 in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. As the disease progresses, intraretinal pigment plaques and eventually subretinal/choroidal neovascularization develop. Currently, these patients will be classified as macular telangiectasia. The pathogenesis of the disease is unknown. Because of the leakage of the retinal vessels and also the finding of neovascularization, it is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of five participants with macular telangiectasia with hyperfluorescence on fluorescein angiography, with vision decreased to 20/40 or worse, without neovascularization. The primary outcome will be a visual acuity change, either increase or decrease of 15 letters or more at one year. The secondary outcomes measured at one year will include visual acuity changes of 10 letters or more, the change in retinal thickening documented by OCT, the extent and degree of fluorescein leakage, the change in area of hypofluorescence, and the change in central retinal sensitivity. This is a pilot study designed to evaluate the feasibility and potential efficacy of treating patients with macular telangiectasia in a larger, phase III study within the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation. Currently, the research group is enrolling 200 patients affected with this condition for a natural history study in 22 international clinical centers.
- Conditions
- Telangiectasia
- Being tested
- Ranibizumab
- Keywords
- Hyperfluorescence on Fluorescein, Idiopathic Juxtafoveal Telangiectasia, Retinal Edema/Thinning, Vascular Endothelial Growth Factor, Macular Telangiectasia
- Medical subject headings
- Telangiectasis, Idiopathic Juxtafoveal Retinal Telangiectasia, Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study start27 Mar 2007
- Study completion24 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457145
- Sponsor's protocol ID
- 070096
- Other IDs
- 07-EI-0096
- Status last verified
- 24 Oct 2007
- First submitted
- 4 Apr 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gass JD. Histopathologic study of presumed parafoveal telangiectasis. Retina. 2000;20(2):226-7. doi: 10.1097/00006982-200002000-00028. No abstract available.
PubMed 10783967
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia Without Neovascularization
- ClinicalTrials.gov ID
- NCT00457145
- Acronym / sponsor ID
- 070096
- Conditions
- Telangiectasia
- Keywords
- Hyperfluorescence on Fluorescein, Idiopathic Juxtafoveal Telangiectasia, Retinal Edema/Thinning, Vascular Endothelial Growth Factor, Macular Telangiectasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 27 Mar 2007
- Study completion
- 24 Oct 2007
- First posted
- 5 Apr 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.
This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where new vessel formation under the retina is absent.
Patients 18 years of age and older who have macular telangiectasia without new blood vessel formation may be eligible for this study. Visual acuity must be 20/40 or worse.
Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures:
- Medical history and physical examination.
- Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye.
- Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina.
- Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.
- Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light.
- Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.
- Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture.
- Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.
Detailed description
Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the former group 2 in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. As the disease progresses, intraretinal pigment plaques and eventually subretinal/choroidal neovascularization develop. Currently, these patients will be classified as macular telangiectasia. The pathogenesis of the disease is unknown. Because of the leakage of the retinal vessels and also the finding of neovascularization, it is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of five participants with macular telangiectasia with hyperfluorescence on fluorescein angiography, with vision decreased to 20/40 or worse, without neovascularization. The primary outcome will be a visual acuity change, either increase or decrease of 15 letters or more at one year. The secondary outcomes measured at one year will include visual acuity changes of 10 letters or more, the change in retinal thickening documented by OCT, the extent and degree of fluorescein leakage, the change in area of hypofluorescence, and the change in central retinal sensitivity. This is a pilot study designed to evaluate the feasibility and potential efficacy of treating patients with macular telangiectasia in a larger, phase III study within the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation. Currently, the research group is enrolling 200 patients affected with this condition for a natural history study in 22 international clinical centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (12 listed)
- Participant has neovascularization in either eye.
- History (within past 5 years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
- History of stroke within 12 months of study entry.
- History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
- Current acute ocular or periocular infection.
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 |
|---|---|---|
| Ranibizumab | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 10783967Gass JD. Histopathologic study of presumed parafoveal telangiectasis. Retina. 2000;20(2):226-7. doi: 10.1097/00006982-200002000-00028. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ranibizumab in people with Telangiectasia, run by National Eye Institute (NEI) at 1 site in United States.
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 7 inclusion and 12 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 2 Jul 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457145, which also lists 1 linked publication.
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 2 Jul 2017.