Evaluating brolucizumab for treating diabetic macular edema

Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

This study is testing if a new eye injection called brolucizumab can help Chinese patients with persistent diabetic macular edema improve their vision and eye health.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Drugs / interventions: Ranibizumab, brolucizumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06498050 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of brolucizumab 6 mg in Chinese patients suffering from persistent diabetic macular edema (DME). Participants will receive intravitreal injections of brolucizumab according to two treatment patterns over a 28-week period, with multiple assessments of central subfield thickness and best-corrected visual acuity. The study will monitor any adverse events and compare baseline measurements to those taken at various follow-up visits to determine the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes and specific visual impairment due to DME.

Not a fit: Patients with visual impairment not caused by diabetic macular edema or those with uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and reduce retinal swelling in patients with diabetic macular edema.

How similar studies have performed: Previous studies have shown promising results with similar anti-VEGF treatments for diabetic macular edema, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent had to be obtained prior to participation in the study.
2. Patients ≥18 years of age at screening.
3. Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
4. Study Eye: Visual impairment due to DME with: (1) BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline. (2)DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limiting membrane (ILM) inclusively) of ≥320 μm on SD-OCT at screening. (Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality) (3) Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs. (4) Diagnosis of DME less than 6 months prior to enrollment. (5) Have at least 3 intravitreal injections of the same anti-VEGF medication (Ranibizumab, Aflibercept, or Conbercept) within the 20 weeks prior to enrollment.

Exclusion Criteria:

1. Active Proliferative Diabetic Retinopathy in the study eye as per investigator.
2. Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention for the duration of the study (e.g. cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
3. Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline, or any history of intraocular inflammation.
4. Presence of amblyopia, amaurosis or ocular disorders with vision \<20/200 (35 letters) in the fellow eye at screening or baseline.
5. History of idiopathic or autoimmune uveitis in the study eye.
6. Any history of intravitreal anti-VEGF treatment in study eye during the 28 days prior to baseline.
7. Use of fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time. Prior use of other intraocular or periocular corticosteroids in the study eye is not an exclusion provided at least 6-month wash-out prior to baseline.
8. Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 months prior to baseline.
9. History of vitreoretinal surgery in study eye.
10. Stroke or myocardial infarction during the 6 month period prior to baseline.
11. Any history of renal failure requiring dialysis or kidney transplantation or any history of kidney transplantation.
12. Poor blood pressure control（SBP≥180 mmHg or DBP≥100 mmHg）
13. Any history of systemic anti-VEGF treatment during the 3 months prior to baseline
14. Pregnancy

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Honghua Yu — Guangdong Provincial People's Hospital
• Study coordinator: Ying Fang

Conditions: Diabetic Macular Edema, diabetic macular edema, brolucizumab, central subfield thickness, visual acuity, anti-VEGF