Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304954
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2006-03-17
Brief Title:
Infliximab Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response
Status:
COMPLETED
Status Verified Date:
2016-11
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:
AMDB1
Brief Summary:
This study examined whether the anti-inflammatory medicines infliximab sirolimus or daclizumab when given with a participants current therapies would prevent the growth of new blood vessels in the eye in participants with age-related macular degeneration AMD
Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible for this study Vision in the study eye was between 2020 and 20400
Participants were randomly assigned to one of three treatments - infliximab sirolimus or daclizumab - or to observation only In addition participants may have been treated by their ophthalmologist as needed for their AMD
Infliximab and daclizumab were given intravenously through a vein infusions were given at enrollment in the study then at 2 weeks and then monthly
Sirolimus was a pill that was taken every other day for the duration of the study At 6 months participants were evaluated to see whether continuing treatment would be beneficial
In addition to treatment or observation participants underwent the following procedures
Physical examination at enrollment and 6 months
Photographs of the back of the eye fluorescein angiography indocyanine green angiography and measurement of retinal thickness at enrollment and months 1 3 and 6
Fluorescein angiography evaluated the eyes blood vessels A yellow dye was injected into an arm vein and traveled to the blood vessels in the eyes Pictures of the retina were taken using a camera that flashed a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Indocyanine green angiography identified feeder vessels that may have supplied abnormal blood vessels This procedure is similar to fluorescein angiography but uses a green dye and flashes an invisible light
Optical coherence tomography measures retinal thickness This test shines a light into the eye and produces cross-sectional pictures of the retina These measurements are repeated during the study to determine whether retinal thickening is getting better or worse or staying the same
Tuberculin skin test and chest x-ray at enrollment and 6 months
Blood tests at enrollment and months 1 3 and 6
Participants 55 years of age and older with AMD and drusen larger than 63um may be eligible for this study Vision in the study eye was between 2020 and 20400
Participants were randomly assigned to one of three treatments - infliximab sirolimus or daclizumab - or to observation only In addition participants may have been treated by their ophthalmologist as needed for their AMD
Infliximab and daclizumab were given intravenously through a vein infusions were given at enrollment in the study then at 2 weeks and then monthly
Sirolimus was a pill that was taken every other day for the duration of the study At 6 months participants were evaluated to see whether continuing treatment would be beneficial
In addition to treatment or observation participants underwent the following procedures
Physical examination at enrollment and 6 months
Photographs of the back of the eye fluorescein angiography indocyanine green angiography and measurement of retinal thickness at enrollment and months 1 3 and 6
Fluorescein angiography evaluated the eyes blood vessels A yellow dye was injected into an arm vein and traveled to the blood vessels in the eyes Pictures of the retina were taken using a camera that flashed a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Indocyanine green angiography identified feeder vessels that may have supplied abnormal blood vessels This procedure is similar to fluorescein angiography but uses a green dye and flashes an invisible light
Optical coherence tomography measures retinal thickness This test shines a light into the eye and produces cross-sectional pictures of the retina These measurements are repeated during the study to determine whether retinal thickening is getting better or worse or staying the same
Tuberculin skin test and chest x-ray at enrollment and 6 months
Blood tests at enrollment and months 1 3 and 6
Detailed Description:
There has been much interest in the possible role of the immune system in AMD Experimental models and patient material have to date suggested a role for macrophages and complement This study hypothesized that the underlying mechanism that leads to choroidal neovascularization CNV is similar to those at play in atherosclerosis If this is the case the investigators believed that CNV treatment should be amenable to new immunomodulatory agents directed against specific parts of the immune system
After therapy with anti-angiogenic agents not leading to a persistent remission of CNV due to AMD participants were treated with one of three immunomodulatory agents or were observed in conjunction with their continued anti-angiogenic therapy Thus the participant continued with the anti-angiogenic therapy they received after randomization The investigators hypothesized that this combination therapy would inhibit progression of CNV associated with AMD
This was an open-label phase II randomized single center clinical trial of 18 study participants randomized to receive one of three immunomodulatory agents or was observed in conjunction with their anti-angiogenic therapy
After therapy with anti-angiogenic agents not leading to a persistent remission of CNV due to AMD participants were treated with one of three immunomodulatory agents or were observed in conjunction with their continued anti-angiogenic therapy Thus the participant continued with the anti-angiogenic therapy they received after randomization The investigators hypothesized that this combination therapy would inhibit progression of CNV associated with AMD
This was an open-label phase II randomized single center clinical trial of 18 study participants randomized to receive one of three immunomodulatory agents or was observed in conjunction with their anti-angiogenic therapy
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 |
|---|---|---|---|
| 06-EI-0111 | OTHER | NEI | None |