Diabetic Macular Edema (DME)Phase 4NCT06882551
Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients
A Phase 4 study testing Intravitreal Bevacizumab IVB and intravitreal bevacizumab and suprachoroidal triamcinolone acetonide in people with Diabetic Macular Edema (DME), run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema Read more about this study
- Who is it for?
- Ages 32 to 78 years
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Intravitreal Bevacizumab IVB and intravitreal bevacizumab and suprachoroidal triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 15 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 32 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with center involving diabetic macular edema on optical coherence tomography
Who cannot join
- Raised intraocular pressure
- History of glaucoma
- Corneal opacity
- Vitreous hemorrhage
- Proliferative diabetic retinopathy
- Anti-VEGF injections in last 3 months
- History of pan-retinal photocoagulation
- Contraindications for anti-VEGF
Trial locations and contacts
1 site in 1 country.
About this study
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema
Read the detailed description
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Intravitreal Bevacizumab IVB, intravitreal bevacizumab and suprachoroidal triamcinolone acetonide
- Keywords
- intravitreal bevacizumab, suprachoroidal triamcinolone, diabetic macular edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Bevacizumab IVBDrug
Intravitreal bevacizumab alone
intravitreal bevacizumab and suprachoroidal triamcinolone acetonideDrug
Combination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Bevacizumab alone for center involving diabetic macular edema | Experimental | Effect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema Receives: Drug: Intravitreal Bevacizumab IVB |
| Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab | Experimental | Combination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema Receives: Drug: intravitreal bevacizumab and suprachoroidal triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Effect of both treatment on central macular thickness measure on optical coherence tomography
Measured: 3 months
Visual Acuity
Improvement in best corrected visual acuity
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 posted18 Mar 2025
- Study start1 Apr 2023
- Primary completion30 Nov 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
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
- NCT06882551
- Sponsor's protocol ID
- KhyberTeH
- Other IDs
- 450/DME/KMC
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmad I, Mahsood YJ. Suprachoroidal Triamcinolone Plus Intravitreal Bevacizumab Versus Bevacizumab Alone for Diabetic Macular Edema in Pseudophakic Eyes: A randomized controlled trial. Pak J Med Sci. 2026 Jun;42(6):1377-1382. doi: 10.12669/pjms.42.6.14576.
PubMed 42369925
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients
- ClinicalTrials.gov ID
- NCT06882551
- Acronym / sponsor ID
- KhyberTeH
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- intravitreal bevacizumab, suprachoroidal triamcinolone, diabetic macular edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 18 Mar 2025 (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.
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema
Detailed description
Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Bevacizumab alone for center involving diabetic macular edema | Experimental | Drug: Intravitreal Bevacizumab IVBEffect of intravitreal Bevacizumab 1.25mg on center involving diabetic macular edema |
| Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab | Experimental | Drug: intravitreal bevacizumab and suprachoroidal triamcinolone acetonideCombination of suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab for the treatment of diabetic macular edema |
Who may qualify
- Ages
- 32 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with center involving diabetic macular edema on optical coherence tomography
Key exclusion criteria (8 listed)
- Raised intraocular pressure
- History of glaucoma
- Corneal opacity
- Vitreous hemorrhage
- Proliferative diabetic retinopathy
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 |
|---|---|---|
| Intravitreal Bevacizumab IVBIntravitreal bevacizumab alone | Drug | Intravitreal Bevacizumab alone for center involving diabetic macular edema |
| intravitreal bevacizumab and suprachoroidal triamcinolone acetonideCombination of Intravitreal bevacizumab and suprachoroidal triamcinolone acetonide | Drug | Suprachoroidal triamcinolone acetonide and intravitreal Bevacizumab |
Primary outcome
Central macular thickness
Time frame: 3 months
Effect of both treatment on central macular thickness measure on optical coherence tomography
Visual Acuity
Time frame: 3 months
Improvement in best corrected visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 42369925Ahmad I, Mahsood YJ. Suprachoroidal Triamcinolone Plus Intravitreal Bevacizumab Versus Bevacizumab Alone for Diabetic Macular Edema in Pseudophakic Eyes: A randomized controlled trial. Pak J Med Sci. 2026 Jun;42(6):1377-1382. doi: 10.12669/pjms.42.6.14576.
- Suprachoroidal injection of triamcinolone acetonide plus intravitreal bevacizumab in diabetic macular edema: a randomized pilot trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 4 study testing Intravitreal Bevacizumab IVB and intravitreal bevacizumab and suprachoroidal triamcinolone acetonide 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 8 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: finished, as of the sponsor's last update on 18 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT06882551, which also lists 1 linked publication.
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 18 Mar 2025.