Diabetic Macular Edema (DME)NCT07338097
Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema
A study testing Aflibercept (2.0 mg) and Bevacizumab in people with Diabetic Macular Edema (DME), run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Aflibercept (2.0 mg) and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Sep 2025to 7 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
CMH Institute of Medical Sciences
Multan, Punjab Province, 66000
About this study
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.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Aflibercept (2.0 mg), Bevacizumab
- Keywords
- Diabetic macular edema, Intravitreal injection, Anti vascular endothelial growth factor, Bevacizumab, Aflibercept, Visual acuity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (2.0 mg)Drug
Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.
BevacizumabDrug
Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.
| Study group | Role | What they receive |
|---|---|---|
| Group Aflibercept | Experimental | Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months. Receives: 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 Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The secondary outcome is the average change in central retinal thickness measured in micrometers using optical coherence tomography. The change is calculated by comparing baseline thickness with the value measured at follow up. This outcome reflects anatomical response of the macula to treatment.
Measured: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start7 Sep 2025
- Primary completion7 Feb 2026 (estimated)
- Study completion7 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMH Multan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sana Javed, CMH Multan Institute of Medical Sciences
- Investigators
- Sana Javed, Principal investigator, CMH Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338097
- Sponsor's protocol ID
- CIMS1
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07338097
- Acronym / sponsor ID
- CIMS1
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Diabetic macular edema, Intravitreal injection, Anti vascular endothelial growth factor, Bevacizumab, Aflibercept, Visual acuity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- CMH Multan Institute of Medical SciencesOther government
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 7 Feb 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Aflibercept | Experimental | Drug: Aflibercept (2.0 mg)Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months. |
| Group Bevacizumab | Active comparator | Drug: BevacizumabParticipants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (2.0 mg)Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months. | Drug | Group Aflibercept |
| BevacizumabIntravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months. | Drug | Group Bevacizumab |
Primary outcome
Mean Change in Visual Acuity Letter Score
Time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.
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.
1 secondary outcome
Mean Change in Central Retinal Thickness
Time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sana Javed principal investigator
CMH Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept (2.0 mg) and Bevacizumab in people with Diabetic Macular Edema (DME), run by CMH Multan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Visual Acuity Letter Score (time frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.