Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043680
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-08-10
Brief Title:
Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multi-Center Randomized Phase III Trial to Study the Effects of Cyclooxygenase-2 Inhibition on the Response to Photodynamic Therapy in Patients With Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2005-01
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 determine whether the drug celecoxib Celebrex Registered Trademark can help stabilize or improve vision in patients with age-related macular degeneration AMD who are receiving photodynamic therapy or PDT also called cold laser treatment The macula is the part of the retina in the back of the eye that determines central or best vision AMD can severely impair central vision affecting a persons ability to read drive and carry out daily activities This vision loss is caused by the formation of abnormal new blood vessels in the choroid-a thin pigmented vascular layer of the eye behind the retina-that leak blood under the macula PTD stops the growth of these blood vessels and slows the rate of vision loss However the treatment usually does not cause vision to improve and it has only a temporary effect requiring several treatments over 2 years Furthermore PDT does not work in all patients and may actually cause some swelling and re-growth of blood vessels Celecoxib is an anti-inflammatory drug that in animal studies has prevented the growth of abnormal blood vessels associated with tumors and with injury to the cornea Thus the drug might reduce swelling and prevent vessel re-growth in AMD enhancing the effectiveness of PDT
Patients 55 years of age and older with AMD and visual acuity of 2020 to 20200 may be eligible for this study Participants will be randomly assigned to take either celecoxib or a placebo a look-alike pill with no active drug twice a day and undergo the various tests and procedures detailed below Not every examination will be done at every visit but all may be required at one visit
Medical history and physical examination
Blood drawing A blood sample is drawn from an arm vein to evaluate liver and kidney function
Eye examination Visual acuity and eye pressure are measured and the lens retina pupils and eye movements are examined
Photography Photographs of the eye are taken using a special camera with a bright flash
Fluorescein angiography Pictures of the retina are taken to look for abnormal blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes The retina is photographed using a camera that flashes 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 This procedure similar to fluorescein angiography uses a green dye to photograph the retina and identify portions of abnormal vessels in the deepest part of the retina
Optical coherence tomography This new technique uses light to produce a 2-dimensional cross-sectional picture of the retina The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights first with one eye and then the other
One week after starting the study medications laser treatment will begin For this procedure a needle is placed in an arm vein and a chemical called verteporfin Visudyne Registered Trademark is infused into the vein over 10 minutes After 15 minutes the eye is anesthetized with numbing drops A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds
Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations and possible re-treatment if needed Some patients will be asked to return 1 to 2 weeks after the first PDT for an eye examination and fluorescein angiography
Patients 55 years of age and older with AMD and visual acuity of 2020 to 20200 may be eligible for this study Participants will be randomly assigned to take either celecoxib or a placebo a look-alike pill with no active drug twice a day and undergo the various tests and procedures detailed below Not every examination will be done at every visit but all may be required at one visit
Medical history and physical examination
Blood drawing A blood sample is drawn from an arm vein to evaluate liver and kidney function
Eye examination Visual acuity and eye pressure are measured and the lens retina pupils and eye movements are examined
Photography Photographs of the eye are taken using a special camera with a bright flash
Fluorescein angiography Pictures of the retina are taken to look for abnormal blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes The retina is photographed using a camera that flashes 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 This procedure similar to fluorescein angiography uses a green dye to photograph the retina and identify portions of abnormal vessels in the deepest part of the retina
Optical coherence tomography This new technique uses light to produce a 2-dimensional cross-sectional picture of the retina The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights first with one eye and then the other
One week after starting the study medications laser treatment will begin For this procedure a needle is placed in an arm vein and a chemical called verteporfin Visudyne Registered Trademark is infused into the vein over 10 minutes After 15 minutes the eye is anesthetized with numbing drops A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds
Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations and possible re-treatment if needed Some patients will be asked to return 1 to 2 weeks after the first PDT for an eye examination and fluorescein angiography
Detailed Description:
Age-related macular degeneration AMD represents the most common cause of blindness in patients over the age of 60 The major cause of vision loss in this disease is due to the development of choroidal neovascularization Several clinical trials have shown that eyes with predominately well-defined areas of neovascularization lesions having at least 50 of vessels which can be readily demarcated with fluorescein angiography can benefit from treatment with photodynamic therapy PDT However this treatment benefit only results in a reduction in the number of patients who suffer severe vision loss Few patients demonstrate an improvement in visual acuity In addition other neovascular lesions such as those with predominate occult vessels that are difficult to outline by fluorescein angiography or pure occult do not demonstrate any substantial treatment benefit
Histopathologic studies have demonstrated the presence of an inflammatory response in the retina of patients with choroidal neovascularization as well as in eyes receiving PDT In addition in eyes receiving PDT a vascular remodeling and continued neovascular process occurs Therefore the use of celecoxib Celebrex Registered Trademark a specific cyclooxygenase-2 inhibitor which possesses both anti-angiogenic as well as anti-inflammatory properties may be beneficial in patients with neovascular AMD undergoing PDT
The study will be organized as a double-masked randomized placebo-controlled prospective multi-center clinical trial to investigate the ability of celecoxib to alter the inflammatory and neovascular responses in AMD patients undergoing PDT The results of this study will contribute to the design of a larger definitive clinical trial The primary outcome measure is a drop of 15 letters or more in best corrected visual acuity following initial PDT treatment at 1 year The secondary outcome measures are stabilization drop of 4 letters of less from baseline or improvement of best corrected visual acuity following initial PDT treatment at week 36 and an improvement by 5 or more letters in visual acuity from baseline to week 36 time to retreatment with PDT number of retreatments with PDT and a change in the CNV size the extent of leakage and staining detected by fluorescein angiography Additional outcome measures will be the change in size and extent of vascular remodeling and choroidal new vessel formation as determined by optical coherence tomography OCT and high-speed indocyanine green angiography HS-ICG
Histopathologic studies have demonstrated the presence of an inflammatory response in the retina of patients with choroidal neovascularization as well as in eyes receiving PDT In addition in eyes receiving PDT a vascular remodeling and continued neovascular process occurs Therefore the use of celecoxib Celebrex Registered Trademark a specific cyclooxygenase-2 inhibitor which possesses both anti-angiogenic as well as anti-inflammatory properties may be beneficial in patients with neovascular AMD undergoing PDT
The study will be organized as a double-masked randomized placebo-controlled prospective multi-center clinical trial to investigate the ability of celecoxib to alter the inflammatory and neovascular responses in AMD patients undergoing PDT The results of this study will contribute to the design of a larger definitive clinical trial The primary outcome measure is a drop of 15 letters or more in best corrected visual acuity following initial PDT treatment at 1 year The secondary outcome measures are stabilization drop of 4 letters of less from baseline or improvement of best corrected visual acuity following initial PDT treatment at week 36 and an improvement by 5 or more letters in visual acuity from baseline to week 36 time to retreatment with PDT number of retreatments with PDT and a change in the CNV size the extent of leakage and staining detected by fluorescein angiography Additional outcome measures will be the change in size and extent of vascular remodeling and choroidal new vessel formation as determined by optical coherence tomography OCT and high-speed indocyanine green angiography HS-ICG
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 |
|---|---|---|---|
| 02-EI-0257 | None | None | None |