Ignite Creation Date:
2024-05-05 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00685854
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2008-05-24
Brief Title:
Ranibizumab Injections to Treat Macular Telangiectasia Without New Blood Vessel Growth
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia Without Neovascularization MACTEL 2
Status:
COMPLETED
Status Verified Date:
2011-03-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether the drug ranibizumab Lucentis can help prevent vision loss in people with macular telangiectasia a condition in which new blood vessels grow in the retina at the back of the eye and can leak Such changes in blood vessels are seen in other diseases associated with changes in a body chemical called vascular endothelial growth factor VEGF Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease age-related macular degeneration with similar changes in eye blood vessels
People 18 years of age and older with macular telangiectasia in both eyes with no new blood vessel growth in either eye may be eligible for this study They must have vision better than 20400 in the study eye
Participants undergo the following procedures
Ranibizumab injections in the study eye at least four times over 12 weeks Depending on the response to treatment and the side effects additional injections may be given every 4 weeks for up to 1 year The eye is numbed before the injection and the eye area is cleaned with an antiseptic Antibiotic drops are used for 3 days following the injection to prevent infection
Evaluations before starting treatment at the time of each injection and 8 weeks after the last treatment
History and physical examination
Eye examination with dilation microperimetry and photography The eye examination measures visual acuity eye pressure and eye movements For the microperimetry test subjects sit in front of a computer screen and press a button when they see a light on the screen Measurements and photographs of the retina are also taken
Fluorescein and indocyanine green angiography to examine the blood vessels in the eye A dye called fluorescein or indocyanine green is injected into a vein in the arm The dye travels through the veins to the blood vessels in the eyes A camera takes pictures of the dye as it flows through the blood vessels
Pregnancy test Women who are able to become pregnant have a urine pregnancy test before each ranibizumab injection
People 18 years of age and older with macular telangiectasia in both eyes with no new blood vessel growth in either eye may be eligible for this study They must have vision better than 20400 in the study eye
Participants undergo the following procedures
Ranibizumab injections in the study eye at least four times over 12 weeks Depending on the response to treatment and the side effects additional injections may be given every 4 weeks for up to 1 year The eye is numbed before the injection and the eye area is cleaned with an antiseptic Antibiotic drops are used for 3 days following the injection to prevent infection
Evaluations before starting treatment at the time of each injection and 8 weeks after the last treatment
History and physical examination
Eye examination with dilation microperimetry and photography The eye examination measures visual acuity eye pressure and eye movements For the microperimetry test subjects sit in front of a computer screen and press a button when they see a light on the screen Measurements and photographs of the retina are also taken
Fluorescein and indocyanine green angiography to examine the blood vessels in the eye A dye called fluorescein or indocyanine green is injected into a vein in the arm The dye travels through the veins to the blood vessels in the eyes A camera takes pictures of the dye as it flows through the blood vessels
Pregnancy test Women who are able to become pregnant have a urine pregnancy test before each ranibizumab injection
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 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 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 eight participants with macular telangiectasia with hyperfluorescence on fluorescein angiography with vision better than 20400 without neovascularization The primary outcome of this study will be the proportion of participants that lose 15 letters or more in ETDRS BCVA at 12 months compared with baseline The secondary outcomes measured at one year will include the proportion of participants who lose 10 letters or more the mean change in ETDRS BCVA the change in central retinal thickness the extent of fluorescein leakage the change in fundus autofluorescence change in size of neovascular membrane 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
The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of eight participants with macular telangiectasia with hyperfluorescence on fluorescein angiography with vision better than 20400 without neovascularization The primary outcome of this study will be the proportion of participants that lose 15 letters or more in ETDRS BCVA at 12 months compared with baseline The secondary outcomes measured at one year will include the proportion of participants who lose 10 letters or more the mean change in ETDRS BCVA the change in central retinal thickness the extent of fluorescein leakage the change in fundus autofluorescence change in size of neovascular membrane 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-EI-0147 | None | None | None |