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

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 23letters, inclusive, using ETDRS visual acuity testing charts at a starting testingdistance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) atscreening and baseline. (2)DME involving the center of the macula, with centralsubfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) tothe 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 ofadequate quality) (3) Media clarity, pupillary dilation, and individual cooperationsufficient for adequate OCTs. (4) Diagnosis of DME less than 6 months prior toenrollment. (5) Have at least 3 intravitreal injections of the same anti-VEGFmedication (Ranibizumab, Aflibercept, or Conbercept) within the 20 weeks prior toenrollment.

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 baselinewhich could, in the opinion of the investigator, prevent response to study treatmentor may confound interpretation of study results, compromise visual acuity or requiremedical 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, infectiousblepharitis, uveitis) in study eye at screening or baseline, or any history ofintraocular inflammation.

4. Presence of amblyopia, amaurosis or ocular disorders with vision <20/200 (35letters) 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 daysprior to baseline.

7. Use of fluocinolone acetonide intravitreal implant (Iluvien) in study eye at anytime. Prior use of other intraocular or periocular corticosteroids in the study eyeis 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 3months 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 anyhistory 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