Intensive Glycemic Control Combined With Brolucizumab for Diabetic Macular Edema (iGLY-DME)
Efficacy Evaluation of Combined Intensive Glycemic Control in the Treatment of Diabetic Macular Edema: A Multicenter Randomized Controlled Trial
The purpose of this study is to learn whether tighter control of blood sugar, when combined with the drug brolucizumab, can help people with diabetic macular edema (DME) see better than standard blood sugar care combined with the same drug.
DME is a swelling in the back of the eye that can blur vision. It happens in some people with diabetes. Brolucizumab is an injection into the eye that treats this swelling. Many people improve with this injection, but some do not improve as much as hoped. Researchers think that keeping blood sugar closer to normal may help the eye injection work better.
This study will randomly assign participants to one of two groups. One group will receive intensive blood sugar management, which includes wearing a small sensor that checks sugar levels throughout the day and more frequent check-ins with a diabetes care team. The other group will receive standard blood sugar care. Both groups will receive brolucizumab eye injections on the same schedule.
Researchers will compare how much vision changes in each group over about 6 months. They will also check the amount of swelling in the eye and monitor safety.
This study is for adults with DME who are planning to start brolucizumab treatment. Participants will be in the study for about 6 months and will visit the clinic regularly for eye exams, injections, and blood tests.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background and rationale. Diabetic macular edema (DME) is a leading cause of vision loss in diabetes, driven by hyperglycemia-induced blood-retinal barrier breakdown and VEGF-mediated vascular leakage. While intravitreal anti-VEGF therapy, including brolucizumab, is the current first-line treatment, a substantial proportion of patients show suboptimal anatomic or visual response, and elevated baseline HbA1c has been associated with reduced treatment response. This study is therefore designed to test the exploratory hypothesis that achieving intensive glycemic control, in addition to brolucizumab, may improve visual outcomes beyond standard glycemic care.
Study design. This is a multicenter, randomized, controlled, exploratory superiority trial with assessor masking. Participants are randomized 1:1, stratified by study site, to intensive glycemic management or standard glycemic care; both groups receive identical brolucizumab treatment. A total of 100 participants will be enrolled across 3-5 sites. The exploratory nature of the trial means that no formal significance threshold for superiority is prespecified; the primary analysis will report the between-group difference in BCVA change from baseline to week 24 with its 95% confidence interval and Cohen's d effect size, to inform the design of future confirmatory trials.
Intervention details. Brolucizumab is administered to both groups on the same schedule: three loading doses at weeks 0, 6, and 12, followed by PRN dosing based on prespecified retreatment criteria (vision loss ≥5 letters, CST increase ≥50 μm, or new IRF/SRF). Intensive glycemic management consists of structured endocrinology-led care using continuous glucose monitoring (CGM), with an individualized HbA1c target (generally <7.0%) and a time-in-range (TIR) goal of >70%, alongside a stepwise escalation protocol for participants not meeting glycemic targets. Standard care consists of routine diabetes education and HbA1c monitoring at ophthalmic visits, with a safety referral pathway for significant glycemic deterioration.
Analysis populations. The primary analysis will use the full analysis set (FAS) under the intention-to-treat principle. A per-protocol set (PPS) will be used for sensitivity analysis, and the safety set (SS) will include all participants receiving at least one dose of study treatment. The primary endpoint will be analyzed using a mixed-effects model with treatment group as a fixed factor, baseline BCVA as a covariate, and study site as a random effect.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Age ≥ 18 years.
Clinically diagnosed with type 1 or type 2 diabetes mellitus.
Study eye with diabetic macular edema (DME) confirmed by spectral-domain optical coherence tomography (SD-OCT), with edema involving the foveal center.
Study eye baseline best corrected visual acuity (BCVA) between 24 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, inclusive.
Study eye baseline central subfield thickness (CST) ≥ 250 μm.
Treatment-naive DME, or no anti-VEGF treatment within 3 months and no local or systemic corticosteroid treatment within 6 months prior to enrollment; and no planned vitrectomy.
Planned to receive brolucizumab for DME after assessment and shared decision-making by the treating ophthalmologist prior to enrollment.
Exclusion Criteria:
Presence of other ocular diseases in the study eye that may significantly affect visual acuity or interfere with the assessment of macular edema (e.g., active age-related macular degeneration, retinal vein occlusion, glaucomatous optic neuropathy, high myopic choroidal neovascularization, prior macular hole, or epiretinal membrane involving the macula). Patients with severe proliferative diabetic retinopathy (PDR), high-risk PDR, or PDR stages V and VI.
Prior vitreoretinal surgery (e.g., vitrectomy).
Presence of severe systemic diseases that may interfere with study assessments or increase treatment risks, including but not limited to: poorly controlled heart failure (NYHA Class III-IV), myocardial infarction or unstable angina within the past 6 months, new or unstable stroke within 6 months, end-stage renal disease (e.g., requiring dialysis), hypertensive crisis, or active malignancy.
Pregnant or lactating women, or women of childbearing potential who plan to become pregnant during the study and are unwilling to use effective contraception.
Known hypersensitivity to brolucizumab or any of its excipients.
Prior retinal laser photocoagulation within 3 months before enrollment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intensive Glycemic Management + Brolucizumab
Participants in this arm will receive intravitreal brolucizumab injections (three loading doses at weeks 0, 6, and 12, followed by pro re nata [PRN] dosing based on prespecified retreatment criteria). In addition, they will receive intensive glycemic management led by an endocrinology team. This includes the use of a continuous glucose monitoring (CGM) system, an individualized HbA1c target (generally <7.0%), a time-in-range (TIR) goal of >70%, and regular follow-up visits (telephone or outpatient) with diabetes specialists to optimize blood sugar control |
A structured, endocrinology-led glycemic management strategy using continuous glucose monitoring (CGM). The intervention targets an individualized HbA1c level (generally <7.0%) and a time-in-range (TIR) of >70%. It includes regular follow-ups (telephone every 2 weeks and outpatient visits every 4 weeks) by a multidisciplinary team for medication adjustment and lifestyle counseling. A stepwise escalation protocol is applied if glycemic targets are not met or severe hypoglycemia occurs. Intravitreal injection of brolucizumab administered on a fixed loading schedule of 3 doses at weeks 0, 6, and 12, followed by pro re nata (PRN) dosing. Retreatment criteria include a best-corrected visual acuity (BCVA) loss of ≥5 ETDRS letters from the best previous measurement, an increase in central subfield thickness (CST) of ≥50 μm, or the presence of new or worsening intraretinal fluid (IRF) or subretinal fluid (SRF). |
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Comparatore attivo: Standard Glycemic Care + Brolucizumab
Participants in this arm will receive intravitreal brolucizumab injections on the same schedule as the other arm (three loading doses at weeks 0, 6, and 12, followed by PRN dosing). For glycemic management, they will receive standard diabetes care, which includes routine diabetes education and HbA1c monitoring at scheduled ophthalmic visits. If significant glycemic deterioration occurs, participants will be referred to endocrinology for safety management, but they will not receive the structured CGM-guided intensive protocol. |
Intravitreal injection of brolucizumab administered on a fixed loading schedule of 3 doses at weeks 0, 6, and 12, followed by pro re nata (PRN) dosing. Retreatment criteria include a best-corrected visual acuity (BCVA) loss of ≥5 ETDRS letters from the best previous measurement, an increase in central subfield thickness (CST) of ≥50 μm, or the presence of new or worsening intraretinal fluid (IRF) or subretinal fluid (SRF). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Best Corrected Visual Acuity (BCVA) in the study eye
Lasso di tempo: From baseline to Week 24
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Change from baseline in BCVA measured as Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye. This will be used for an exploratory superiority comparison between the two groups |
From baseline to Week 24
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Collaboratori e investigatori
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Altri numeri di identificazione dello studio
- KY-2026-164
- K20260210 (Identificatore di registro: Ethics Committee)
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