Status:
ACTIVE_NOT_RECRUITING
Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
Beijing Novartis Pharma
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6...
Detailed Description
This study is a single-arm, open-label study designed to evaluate the efficacy and safety of intravitreal injections (IVI) of brolucizumab 6 mg in Chinese subjects with persistent diabetic macular ede...
Eligibility Criteria
Inclusion
- Signed informed consent had to be obtained prior to participation in the study.
- Patients ≥18 years of age at screening.
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
- 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
- Active Proliferative Diabetic Retinopathy in the study eye as per investigator.
- 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).
- 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.
- Presence of amblyopia, amaurosis or ocular disorders with vision \<20/200 (35 letters) in the fellow eye at screening or baseline.
- History of idiopathic or autoimmune uveitis in the study eye.
- Any history of intravitreal anti-VEGF treatment in study eye during the 28 days prior to baseline.
- 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.
- Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 months prior to baseline.
- History of vitreoretinal surgery in study eye.
- Stroke or myocardial infarction during the 6 month period prior to baseline.
- Any history of renal failure requiring dialysis or kidney transplantation or any history of kidney transplantation.
- Poor blood pressure control（SBP≥180 mmHg or DBP≥100 mmHg）
- Any history of systemic anti-VEGF treatment during the 3 months prior to baseline
- Pregnancy
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06498050
Start Date
July 10 2024
End Date
July 10 2025
Last Update
June 4 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000