Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800679
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2019-12-28
Brief Title:
Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
Combination Therapy for PDR
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
In this randomized 3-armed clinical trial 105 eyes with PDR will be included and divided randomly into 3 groups IVB group 35 eyes that receive 4 monthly IVB injections and then rescue IVB PRP group 35 eyes that undergo full PRP in 2 or 3 sessions and then rescue IVB and combination group 35 eyes that receive 2 bimonthly IVB injections and a modified laser 1 session anterior to the equator and then rescue IVB or laser Diabetic macular edema DME will be treated independently in all groups by IVB Primary outcome will be the number and activity of neovascularizations at 48 and 12 months and secondary measures will be changes in best corrected visual acuity BCVA and central macular thickness CMT and number of examinations and injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None