Status:
UNKNOWN
Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 gro...
Eligibility Criteria
Inclusion
- Presence of PDR with the indication of full PRP according the intend of investigator
- Best corrected visual acuity of 20/320 or better
- Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT
Exclusion
- History of prior PRP with more than 100 burns outside the posterior pole
- Tractional retinal detachment involving the macula
- Evidence of neoplasia of angle on examination
- Macular edema due to a cause other than DME
- Any ocular condition which may change visual acuity during the study
- Substantial cataract which has declined the vision by 3 lines or more
- History of intravitreal injection of anti-VEGF agent in past 2 months
- History of any use of corticosteroid during past 4 months
- History of major intra-ocular surgery except cataract surgery
- History of YAG laser capsulotomy during past 2 months
- Aphakia and uncontrolled glaucoma according to investigator judgment
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04800679
Start Date
March 1 2020
End Date
December 1 2021
Last Update
March 16 2021
Active Locations (1)
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1
Ophthalmic Research Center
Tehran, Iran