Intravitreal Bevacizumab vs Laser vs Combination of Bevacizumab and Modified Laser in PDR
NCT ID: NCT04800679
Last Updated: 2021-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
105 participants
INTERVENTIONAL
2020-03-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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intravitreal bevacizumab injections and then rescue
receive 4 monthly IVB injections and then rescue IVB
IVB group that receive 4 monthly IVB injections and then rescue IVB
PRP group
PRP group
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
IVB injections and a modified laser
IVB injections and a modified laser
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
Interventions
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receive 4 monthly IVB injections and then rescue IVB
IVB group that receive 4 monthly IVB injections and then rescue IVB
PRP group
PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
IVB injections and a modified laser
Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.
Other Identifiers
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97378
Identifier Type: -
Identifier Source: org_study_id
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