Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT04511715
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Non-proliferative Diabetic Retinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravitreal Bevacizumab IVB — DRUG
    Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
  • Follow-up with regular examination for determination of DR progression — OTHER
    regular examination for determination of DR progression

Study Details

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.

Key Dates

First listed
Aug 13, 2020
Start date
Sep 1, 2020
Status verified
Aug 2020
Primary completion
Jan 1, 2021
Completion
Nov 1, 2021

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intravitreal Bevacizumab IVB group
  • Sham Comparator: undergo regular follow-up for Diabetic Retinopathy

Primary Outcome Measure

Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging [ Time Frame: 12 months ]

Central Contacts

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