Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527475
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2007-09-09
Brief Title:
Ranibizumab and Reduced Fluence PDT for AMD
Sponsor:
Texas Retina Associates
Organization:
Texas Retina Associates
Study Overview
Official Title:
Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RAP
Brief Summary:
Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration However they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis lens damage retinal detachment and vitreous hemorrhage The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab
Detailed Description:
A randomized prospective multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD One group will receive 05 mg ranibizumab intraocularly initially This will be repeated monthly for 3 months total and then as needed over the period of one year The other group will receive Reduced Fluence-PDT 25 Joules followed by 05 mg of ranibizumab intraocularly on the same day The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year Re-treatment will be determined by the individual investigator based on visual acuity retinal thickness as measured by optical coherence tomography OCT and fluorescein angiography Visual acuity and OCT measurements will be performed by masked examiners
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