Diabetic Macular Edema (DME)Phase 3Macular EdemaNCT07897630
Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Diabetic Macular Edema
A Phase 3 study testing Bevacizumab in people with Diabetic Macular Edema (DME), run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
Diabetic macular edema is an eye condition caused by diabetes in which fluid accumulates in the central part of the retina, leading to blurred vision and potentially permanent vision loss. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2026to Dec 2027
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with centre involving diabetic macular edema on OCT
Who cannot join
- PDR, corneal opacity, VMT, previous anti-VEGF treatment, previous PRP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Patients With Centre Involving Diabetic Macular Edema- A Randomized Control Trial
Diabetic macular edema is an eye condition caused by diabetes in which fluid accumulates in the central part of the retina, leading to blurred vision and potentially permanent vision loss. Bevacizumab is a medicine that blocks vascular endothelial growth factor (VEGF), a protein involved in abnormal leakage from blood vessels. It is commonly used as an injection into the eye to treat this condition.
This study aims to compare two methods of delivering bevacizumab in patients with center-involving diabetic macular edema. Participants will be randomly assigned to one of two groups. The first group will receive bevacizumab injections into the vitreous cavity of the eye (intravitreal injection), while the second group will receive injections into the space between the sclera and choroid of the eye (suprachoroidal injection). Both groups will receive injections once a month for three months.
Read more
The study will compare changes in vision and central retinal thickness, measured using an eye examination and optical coherence tomography (OCT), from the start of the study to the four-month assessment. The occurrence of treatment-related complications and other adverse events will also be recorded.
The study hypothesis is that suprachoroidal bevacizumab will provide improvements in vision and retinal thickness comparable to intravitreal bevacizumab, with a potentially different safety profile. The findings may help determine whether suprachoroidal delivery is a useful alternative to the established intravitreal route for treating diabetic macular edema.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Bevacizumab
- Keywords
- Diabetic Macular Edema, intravitreal Bevacizumab, Suprachoroidal Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Bevacizumab
BevacizumabDrug
Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Suprachoroidal | Experimental | Suprachoroidal Bevacizumab Injection Receives: Drug: Bevacizumab |
| Intravitreal | Active comparator | Intravitreal Bevacizumab Injection Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Macular Thickness
Central Macular Thickness on Optical Coherence Tomography
Measured: 3 months
Visual Acuity
Visual Acuity on LogMAR
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imran Ahmad, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897630
- Sponsor's protocol ID
- 485/IREB/KTH
- Acronym
- Macular Edema
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Suprachoroidal Bevacizumab Versus Intravitreal Bevacizumab in Patients With Centre Involving Diabetic Macular Edema- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07897630
- Acronym / sponsor ID
- Macular Edema / 485/IREB/KTH
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Diabetic Macular Edema, intravitreal Bevacizumab, Suprachoroidal Bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 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 an eye condition caused by diabetes in which fluid accumulates in the central part of the retina, leading to blurred vision and potentially permanent vision loss. Bevacizumab is a medicine that blocks vascular endothelial growth factor (VEGF), a protein involved in abnormal leakage from blood vessels. It is commonly used as an injection into the eye to treat this condition.
This study aims to compare two methods of delivering bevacizumab in patients with center-involving diabetic macular edema. Participants will be randomly assigned to one of two groups. The first group will receive bevacizumab injections into the vitreous cavity of the eye (intravitreal injection), while the second group will receive injections into the space between the sclera and choroid of the eye (suprachoroidal injection). Both groups will receive injections once a month for three months.
The study will compare changes in vision and central retinal thickness, measured using an eye examination and optical coherence tomography (OCT), from the start of the study to the four-month assessment. The occurrence of treatment-related complications and other adverse events will also be recorded.
The study hypothesis is that suprachoroidal bevacizumab will provide improvements in vision and retinal thickness comparable to intravitreal bevacizumab, with a potentially different safety profile. The findings may help determine whether suprachoroidal delivery is a useful alternative to the established intravitreal route for treating diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprachoroidal | Experimental | Drug: BevacizumabSuprachoroidal Bevacizumab Injection |
| Intravitreal | Active comparator | Drug: BevacizumabIntravitreal Bevacizumab Injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with centre involving diabetic macular edema on OCT
Key exclusion criteria (1 listed)
- PDR, corneal opacity, VMT, previous anti-VEGF treatment, previous PRP
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 |
|---|---|---|
| BevacizumabBevacizumab | Drug | Suprachoroidal |
| BevacizumabBevacizumab | Drug | Intravitreal |
Primary outcome
Central Macular Thickness
Time frame: 3 months
Central Macular Thickness on Optical Coherence Tomography
Visual Acuity
Time frame: 3 months
Visual Acuity on LogMAR
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)
Diabetic Retinopathy, Macular Edema
RecruitingPhase 3
A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
Diabetic Retinopathy, Macular Edema
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab in people with Diabetic Macular Edema (DME), run by Khyber Teaching Hospital 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 1 inclusion and 1 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 27 Oct 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Central Macular Thickness (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 Oct 2026.