Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04511715

Enrollment

100

Registered

2020-08-13

Start date

2020-09-01

Completion date

2021-11-01

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-proliferative Diabetic Retinopathy

Brief 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.

Interventions

DRUGIntravitreal Bevacizumab IVB

Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment

OTHERFollow-up with regular examination for determination of DR progression

regular examination for determination of DR progression

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging	12 months	Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups

Secondary

Measure	Time frame	Description
Best corrected visual acuity	12 months	Best corrected visual acuity based on ETDRS letter scale and logMAR
Central retinal thickness	12 months	Central retinal thickness according to macular ocular coherence tomography
Number of visits	12 months	Number of visits in each time point

Contacts

Primary ContactHomayon Nikkhah, MD

labbafi@hotmail.com009822591616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026