Subgroup Analyses of the COMET trial: "Effectiveness and safety of Combination therapy of anti-VEGF agent (Ranibizumab) and SGLT2i (LuseOgliflozin) in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial"

Subgroup Analyses of the COMET trial: "Effectiveness and safety of Combination therapy of anti-VEGF treatment and SGLT2i in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial" - Subgroup Analyses of the COMET trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057674

Enrollment

Registered

2025-04-25

Start date

2024-09-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic macular edema in type 2 diabetes

Interventions

SGLT2i group The SGLT2 inhibitor (luceogliflozin 2.5 mg) will be taken orally for 48 weeks from the start of the study. The anti-VEGF agents (ranibizumab 0.5 mg) will be injected intravitreousl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants in the COMET trial The selection criteria for the COMET trial are as follows Participants in the COMET trial The inclusion criteria for the COMET trial are as follows Patients who meet all the following criteria are eligible. 1 Type 2 diabetes patients aged 20 years or older and younger than 80 years at the time of obtaining consent. 2 Patients with diabetic macular edema extending to the fovea of the macula in the target eye. Corrected visual acuity 0.05 or higher. 3 Patients whose retinal thickness measured by OCT in the target eye at the time of screening is 350 micrometers or more. However, if both eyes meet the above criteria, the eye with the greater retinal thickness will be the target eye. 4 HbA1c at the time of screening 6.5 percents or more and less than 12.0 percents 5 BMI at the time of screening 18.5 kg/m2 or more 6 eGFR at the time of screening 30 mL/min1.73 m2 or more 7 Stable diabetes treatment for 8 weeks prior to screening. 8 Patients who have received a sufficient explanation of the study and have fully understood it, and who have given their own voluntary written consent to participate.

Exclusion criteria

Exclusion criteria: Patients enrolled in COMETtrial who meet any of the following criteria: 1) Those who have expressed their refusal to participate in this study through an information disclosure document 2) Those who are otherwise deemed inappropriate by the principal investigator

Design outcomes

Primary

Measure	Time frame
The number of anti-VEGF injections up to 48 weeks after the start of the study	—

Countries

Japan

Contacts

Public ContactTOMOAKI TATSUMI

Chiba University Graduate School of Medicine Department of Ophthalmology and Visual Science

ttatsumi@chiba-u.jp0432227171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 11, 2026