Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy
100 participantsStarted 2020-09-01
Plain-language summary
In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema
* Diagnosis of DM (type 1 or 2) with age more than 18 years' old
* Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart
Exclusion Criteria:
* Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization
* History of retinal laser photocoagulation
* Tractional retinal detachment involving the macula
* Evidence of neovascularization of angle on examination
* Macular edema due to a cause other than DME
* Any ocular condition which may change visual acuity during the study
* History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months
* History of any use of intravitreal corticosteroid
* History of major intra-ocular surgery except cataract surgery in the past 6 months
* History of thromboembolic every in the past 3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
Timeframe: 12 months
Trial details
NCT IDNCT04511715
SponsorShahid Beheshti University of Medical Sciences