Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008515
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-01-12
Brief Title:
Fluocinolone Implant to Treat Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Prospective Study of Sustained-Release Fluocinolone Acetonide Implant for Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2001-12
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 test the safety and effectiveness of a fluocinolone implant to treat age-related macular degeneration This eye disease can severely impair central vision affecting a persons ability to read drive and carry out daily activities It is the leading cause of vision loss in people over age 60 The fluocinolone implant is a tiny plastic rod with a pellet of the steroid fluocinolone on the end The pellet slowly dissolves and releases the medication into the fluid in the eye
Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin pigmented vascular layer of the eye behind the retina These abnormal vessels leak blood under the macula the part of the retina that determines central vision Tissue studies show evidence of inflammation in the retinas of patients This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision
Patients 50 years of age and older with age-related macular degeneration may be eligible for this study Study patients will be randomly assigned to one of two treatment groups One will receive a 05-mg dose implant the other will receive a 2-mg dose implant Theoretically the implants can release the medicine for 2 to 3 years
Participants will have a medical history physical examination and complete eye examination The latter will include a vision test eye pressure measurement examination of the pupils lens retina and eye movements Photographs of the eye will be taken with a special camera Patients will also undergo fluorescein angiography a test that takes pictures of the retina using a yellow dye called sodium fluorescein The dye is injected into the blood stream through a vein After it reaches the blood vessels of the eye photographs are taken of the retina
When the above tests are completed patients will be scheduled for surgery to place the implant The procedure will be done under either local or general anesthesia Follow-up visits will be scheduled 1 2 4 and 6 weeks after surgery then at 3 and 6 months after surgery and then every 6 months until the implant is depleted of medicine or is removed Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects if any
Vision loss in macular degeneration is caused by the formation of new blood vessels in the choroid-a thin pigmented vascular layer of the eye behind the retina These abnormal vessels leak blood under the macula the part of the retina that determines central vision Tissue studies show evidence of inflammation in the retinas of patients This study will test whether the slow release of the steroid fluocinolone directly into the affected part of the eye can prevent or slow further vision loss Preliminary animal and human studies with fluocinolone implants have shown some benefit in reducing blood vessel growth and improving or stabilizing vision
Patients 50 years of age and older with age-related macular degeneration may be eligible for this study Study patients will be randomly assigned to one of two treatment groups One will receive a 05-mg dose implant the other will receive a 2-mg dose implant Theoretically the implants can release the medicine for 2 to 3 years
Participants will have a medical history physical examination and complete eye examination The latter will include a vision test eye pressure measurement examination of the pupils lens retina and eye movements Photographs of the eye will be taken with a special camera Patients will also undergo fluorescein angiography a test that takes pictures of the retina using a yellow dye called sodium fluorescein The dye is injected into the blood stream through a vein After it reaches the blood vessels of the eye photographs are taken of the retina
When the above tests are completed patients will be scheduled for surgery to place the implant The procedure will be done under either local or general anesthesia Follow-up visits will be scheduled 1 2 4 and 6 weeks after surgery then at 3 and 6 months after surgery and then every 6 months until the implant is depleted of medicine or is removed Several of the exams described above will be repeated during the follow-up period to evaluate the treatment and side effects if any
Detailed Description:
Age-related macular degeneration AMD represents the most common cause of blindness in patients over the age of 60 Most vision loss in this disease results from sequelae of choroidal neovascular membrane CNVM formation CNVM is usually composed of well-formed neovascularization and occult less well-formed neovascularization While clinical trials have shown that some patients mostly those with well-formed CNVM may benefit from laser photocoagulation or photodynamic therapy at present there is no treatment for patients who have a large component of occult neovascularization
Retinal histopathology of patients with choroidal neovascularization demonstrates the presence of inflammatory and reparative responses We hypothesize that sustained intraocular corticosteroids may be able to down-regulate many of the cellular factors involved in both inflammation and repair resulting in stabilization of CNVM formation and vision We will test this hypothesis using a randomized prospective study Persons having an eligible eye with occult choroidal neovascularization will be randomly assigned to receive either a 05 microgramday or a 2 microgramday sustained-release fluocinolone intravitreal implant The study is designed to provide limited safety and potential efficacy data regarding these sustained intravitreal devices The primary outcome of the study will be implant safety as determined by potential implant related adverse advents These events can be related to the surgical insertion of the intravitreal implants such as endophthalmitis hypotony retinal detachment and hemorrhage those related to complications of the anesthesia such as retrobulbar hemorrhage or complications of general anesthesia if used and those related to intraocular fluocinolone such as development of glaucoma and cataract formation The primary efficacy outcome will be proportion of patients at two years who have not lost two lines or more of visual acuity from baseline best corrected visual acuity has improved remained stable or deteriorated by no more than 9 letters Secondary efficacy outcome measures will include the size of predominate occult CNVM as determined by fluorescein angiography and visual function as measured by the NEI VFQ This study will allow investigators to determine some of the potential risks for patients receiving intravitreal fluocinolone and may provide insight into the potential role of the intravitreal placement of steroids in the treatment of predominate occult CNVM associated with AMD
Retinal histopathology of patients with choroidal neovascularization demonstrates the presence of inflammatory and reparative responses We hypothesize that sustained intraocular corticosteroids may be able to down-regulate many of the cellular factors involved in both inflammation and repair resulting in stabilization of CNVM formation and vision We will test this hypothesis using a randomized prospective study Persons having an eligible eye with occult choroidal neovascularization will be randomly assigned to receive either a 05 microgramday or a 2 microgramday sustained-release fluocinolone intravitreal implant The study is designed to provide limited safety and potential efficacy data regarding these sustained intravitreal devices The primary outcome of the study will be implant safety as determined by potential implant related adverse advents These events can be related to the surgical insertion of the intravitreal implants such as endophthalmitis hypotony retinal detachment and hemorrhage those related to complications of the anesthesia such as retrobulbar hemorrhage or complications of general anesthesia if used and those related to intraocular fluocinolone such as development of glaucoma and cataract formation The primary efficacy outcome will be proportion of patients at two years who have not lost two lines or more of visual acuity from baseline best corrected visual acuity has improved remained stable or deteriorated by no more than 9 letters Secondary efficacy outcome measures will include the size of predominate occult CNVM as determined by fluorescein angiography and visual function as measured by the NEI VFQ This study will allow investigators to determine some of the potential risks for patients receiving intravitreal fluocinolone and may provide insight into the potential role of the intravitreal placement of steroids in the treatment of predominate occult CNVM associated with AMD
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 |
|---|---|---|---|
| 01-EI-0058 | None | None | None |