NCT07338097

Brief Summary

Diabetic macular edema is a frequent complication of long-standing diabetes mellitus in which fluid leaks into the central part of the retina (macula), leading to reduced vision. This randomized controlled trial will be conducted at Combined Military Hospital, Multan, to compare two commonly used intravitreal anti vascular endothelial growth factor medicines, aflibercept and bevacizumab, in adults aged 30 to 60 years with type 1 or type 2 diabetes mellitus for at least 5 years, central macular thickness of at least 300 micrometers on optical coherence tomography, and reduced baseline visual acuity (20/50 or worse). Eligible participants will be allocated in a 1:1 ratio to receive either intravitreal aflibercept 2.0 mg or intravitreal bevacizumab 1.25 mg, administered monthly for two months, with follow-up assessments at 1 and 2 months. The primary hypothesis is that aflibercept produces a greater average improvement in visual acuity than bevacizumab in this patient group. The primary outcome is the mean change in visual acuity measured as Early Treatment Diabetic Retinopathy Study letter score from baseline to 2 months. The secondary outcome is the mean change in central retinal thickness on optical coherence tomography.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 3, 2026

Last Update Submit

January 3, 2026

Conditions

Diabetic Macular Edema (DME)

Keywords

Diabetic macular edemaIntravitreal injectionAnti vascular endothelial growth factorBevacizumabAfliberceptVisual acuity

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Visual Acuity Letter Score

    The primary outcome is the average change in visual acuity expressed as Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, calculated by converting Snellen visual acuity measurements. The change is determined by subtracting baseline letter score from the letter score measured at follow up. This metric reflects functional improvement in vision.

    Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.

Secondary Outcomes (1)

  • Mean Change in Central Retinal Thickness

    Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.

Study Arms (2)

Group Aflibercept

EXPERIMENTAL

Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.

Drug: Aflibercept (2.0 mg)

Group Bevacizumab

ACTIVE COMPARATOR

Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months

Drug: Bevacizumab

Interventions

Aflibercept (2.0 mg)DRUG

Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.

Group Aflibercept
BevacizumabDRUG

Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.

Group Bevacizumab

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with type 1 or type 2 diabetes mellitus for ≥5 years
  • Baseline visual acuity of 20/50 or worse
  • Central macular thickness of ≥300 µm on OCT
  • Age 30 to 60 years
  • Either gender
  • Provided voluntary consent for participation

You may not qualify if:

  • History of prior treatment for DME: anti-VEGF, steroids, or laser.
  • Active ocular infection or inflammation
  • History of cardiac disease or stroke
  • Women who are pregnant or breastfeeding
  • Known allergy to Aflibercept or Bevacizumab
  • Patient refusals to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Institute of Medical Sciences

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Interventions

afliberceptBevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sana Javed

    CMH Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 13, 2026

Study Start

September 7, 2025

Primary Completion

February 7, 2026

Study Completion

February 7, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

PA(1)