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Diabetic Macular EdemaPhase 2DAPA-DMENCT06845163

Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema

A Phase 2 study testing Dapagliflozin and Anti-VEGF drug in people with Diabetic Macular Edema and Center-involved Diabetic Macular Edema, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Dapagliflozin and Anti-VEGF drug
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteEgypt
Study dates
8 Feb 2025to 14 Jul 2026
Phase
Phase 2
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type II diabetes mellitus patients, treated with premixed insulin and metformin, and diagnosed with center-involved diabetic macular edema (CiDME)
  • Presence of retinal thickening involving the center of the fovea (CiDME) in the study eye on Optical Coherence Tomography (OCT) Heidelberg Spectralis; If both eyes are eligible, the eye with the greater central subfield thickness on OCT is selected as the study eye.
  • Decreased visual acuity primarily attributable to DME
  • Clear ocular media and pupillary dilation for adequate retinal imaging
  • Ability to understand the study procedures and willingness to provide written informed consent
  • Study participant exclusion criteria:
Show all 39Show fewer
  • Patients below 18 years old and patients above 85 years old
  • Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)
  • Pregnant women and lactating women diagnosed with diabetes or intending to become pregnant in the next 12 months
  • Patients who had myocardial infarction within 3 months prior to screening
  • Patients who had transient ischemic attack (TIA), ischemic or hemorrhagic stroke within 3 months prior to screening
  • Patients with poorly controlled diabetes mellitus, defined as patients having glycosylated hemoglobin (HbA1c) level of ≥12% at screening or patients who were hospitalized for diabetic ketoacidosis or hyperosmolar coma within 4 months prior to screening
  • Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening
  • Patients with severe hepatic impairment of Child-Turcotte-Pugh class C at screening
  • Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone and pioglitazone) prior to screening
  • Patients who were receiving SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, or empagliflozin) within 3 months prior to screening
  • Known allergy or hypersensitivity to any component of the study drugs
  • Current or previous participation in another clinical study involving the systemic or ocular administration of an investigational drug or device within 6 months of screening
  • Study eye exclusion criteria:
  • Macular edema caused by other conditions than diabetic macular edema or coexisting with DME such as retinal vein occlusion, choroidal neovascularization (CNV), or uveitic cystoid macular edema
  • History of postoperative cystoid macular edema (Irvine-Gass syndrome)
  • Cataract extraction within 3 months prior to screening
  • Patients who had previous macular laser treatment
  • Patients who had peripheral panretinal photocoagulation laser (PRP) treatment within 6 months prior to screening
  • Patients who have been treated with intravitreal anti-VEGF or intravitreal corticosteroids within 6 months prior to screening
  • The use of corticosteroids or non-steroidal anti-inflammatory eye drops within 1 month prior to screening
  • Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, or tafluprost) at screening
  • History of vitrectomy or scleral buckling
  • Presence of diffuse vitreomacular traction or thick epiretinal membrane on OCT causing significant traction
  • Presence of tractional retinal detachment involving the macula and requiring vitrectomy
  • Presence of other associated macular pathology (e.g., macular scars or macular holes) on OCT
  • Presence of rubeosis iridis
  • Signs of hypertensive retinopathy (arterioral spasm or silver wiring of blood vessels)
  • Presence of glaucoma
  • Aphakia
  • Yttrium aluminum garnet (YAG) laser capsulotomy within 3 months prior to screening
  • Patients diagnosed with ocular surface infections until treated prior to receiving the intravitreal injections
  • Non-study eye exclusion criteria:
  • The non-study eye receiving simultaneous intravitreal anti-VEGF treatment with the study eye

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University

    Alexandria, Alexandria Governorate

Other trials in Egypt

About this study

Official title: Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema

The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. The main question the study aims to answer is: Does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-VEGF therapy more than the intravitreal anti-VEGF therapy alone?

Read the detailed description

Some evidence in the literature suggests that sodium glucose co-transporter 2 (SGLT2) inhibitors may be beneficial in reducing diabetic macular edema. The objective of this clinical trial is to investigate the efficacy and safety of dapagliflozin when combined with intravitreal aflibercept injections in the management of patients with type II diabetes mellitus and center-involved diabetic macular edema (ci-DME). This randomized, double-blind, parallel group, active control design, clinical trial, is investigating the effect of oral dapagliflozin 10 mg given once daily in addition to intravitreal aflibercept versus intravitreal aflibercept alone on reducing macular central subfield thickness (CST) and improving visual acuity in diabetic patients with ci-DME.

Being tested
Dapagliflozin, Anti-VEGF drug
Keywords
Diabetic Macular Edema, center-involved diabetic macular edema, Anti-VEGF, Aflibercept, EYLEA, Dapagliflozin, Forxiga, SGLT2 inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Forxiga 10 mg

    Dapagliflozin 10 mg will be given orally once daily for three months.

  • Anti-VEGF drugDrug

    Also called Aflibercept (Eylea)

    Aflibercept 2 mg (0.05 ml) will be administered by intravitreal injection every month for three consecutive months.

Study groups in NCT06845163
Study groupRoleWhat they receive
Treatment groupExperimentalThe treatment group will receive oral dapagliflozin 10 mg daily in addition to standard of care intravitreal aflibercept injections.
Receives: Drug: Dapagliflozin; Drug: Anti-VEGF drug
Control groupActive comparatorThe control group will receive standard of care intravitreal aflibercept injections.
Receives: Drug: Anti-VEGF drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean central subfield thickness (CST)

    The reduction in mean central subfield thickness (CST) from baseline will be determined using Optical Coherence Tomography (OCT) and compared between study groups.

    Measured: Baseline, 3 months

  2. The best-corrected visual acuity (BCVA)

    The improvement in the best-corrected visual acuity (BCVA) from baseline will be recorded and compared between study groups.

    Measured: Baseline, 3 months

Secondary outcomes (5)

  1. Percentage of patients with persistent macular edema

    The number of patients with persistent macular edema who are indicated to continue intravitreal anti-VEGF therapy beyond the initial 3 injections will be compared across study groups.

    Measured: 3 months

  2. Retinal anatomical changes

    Retinal anatomical changes such as the improvement of cystoid macular spaces and resolution of subretinal fluid will be determined on OCT.

    Measured: Baseline, 3 months

  3. Visual impairment patient reported outcome

    Patient reported outcome measures for visual impairment will be reported at baseline and after receiving interventions, using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25), and compared across study groups.

    Measured: Baseline, 3 months

  4. Incidence of adverse events

    Systemic and ocular adverse events will be recorded and compared across study groups to assess the safety profile of the interventions.

    Measured: 3 months

  5. Measuring the levels of some inflammatory cytokines in the aqueous humor

    The routinely withdrawn aqueous humor samples from patients with DME during intravitreal anti-VEGF injection will be collected and analyzed. The levels of inflammatory cytokines VEGF-A, interleukin (IL)-6, monocyte chemoattractant protein 1 (MCP-1), and tumor necrosis factor (TNF)-α, will be quantified, using multiplex protein analysis, and compared between the study groups.

    Measured: Baseline, 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start8 Feb 2025
  3. Primary completion14 Jul 2026
  4. Study completion14 Jul 2026

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845163
Sponsor's protocol ID
0202071
Acronym
DAPA-DME
Status last verified
Sep 2026
First submitted
20 Feb 2025
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin and Anti-VEGF drug in people with Diabetic Macular Edema and Center-involved Diabetic Macular Edema, run by Alexandria University at 1 site in Egypt.

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 39 inclusion and 0 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 26 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean central subfield thickness (CST) (time frame: Baseline, 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 NCT06845163.

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 26 Oct 2026.

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