Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140803
Status:
COMPLETED
Last Update Posted:
2007-07-12
First Post:
2005-08-30
Brief Title:
Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
A Randomized Single-Masked Multi-Center Phase 2 Evaluation Of The Effect Of PDT Using Visudyne In Combination With Intravitreal Injection Of Either 0 mg 1mg or 4mg of Kenalog In Subfoveal Occult Minimally Classic CNV Secondary To ARMD
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity BCVA as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation
Detailed Description:
This is a randomized single-masked VA examiners angiographic graders multi-center Phase 2 study with 3 arms comparing VISUDYNE therapy in combination with intravitreal injection of either a 1 mg or 4 mg of triamcinolone with VISUDYNE therapy without intravitreal triamcinolone in a 111 ratio
Re-treatment may be administered at 3 month intervals 14 days if evidence of CNV leakage is detected by fluorescein angiography
At baseline and at 3 month 14 days intervals patients will undergo the following assessments ophthalmic examination best corrected visual acuity fluorescein angiography and color fundus photography The eligibility criteria for inclusion into the study and re-treatment of patients will be based on fluorescein angiography Patients receiving treatment at day-1 week-3 and week-6 following the treatment will have best corrected ETDRS visual acuity testing and ophthalmic Those patients not being re-treated will have will have best corrected ETDRS visual acuity testing and ophthalmic examination at week-6 following the re-treatment evaluation visit
Adverse events will be assessed throughout the study
Expected time for recruitment is 6 months all patients will be followed for the period of 12 months in the study
Re-treatment may be administered at 3 month intervals 14 days if evidence of CNV leakage is detected by fluorescein angiography
At baseline and at 3 month 14 days intervals patients will undergo the following assessments ophthalmic examination best corrected visual acuity fluorescein angiography and color fundus photography The eligibility criteria for inclusion into the study and re-treatment of patients will be based on fluorescein angiography Patients receiving treatment at day-1 week-3 and week-6 following the treatment will have best corrected ETDRS visual acuity testing and ophthalmic Those patients not being re-treated will have will have best corrected ETDRS visual acuity testing and ophthalmic examination at week-6 following the re-treatment evaluation visit
Adverse events will be assessed throughout the study
Expected time for recruitment is 6 months all patients will be followed for the period of 12 months in the study
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