Diabetic Macular Edema MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women =18 years of age (or country’s legal age of adulthood if the legal age is >18 years) with type 1 or type 2 diabetes mellitus 2. Diabetic macular edema (DME) with central involvement in the study eye with central retinal thickness (CRT) =300 µm (or = 320 µm on Spectralis) as determined by the reading center at the screening visit 3. Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide informed consent signed by study patient or legally acceptable representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 362 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 278
Exclusion criteria
Exclusion criteria: 1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye 2. Active proliferative diabetic retinopathy in the study eye 3. IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP)/macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye 4. Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time 5. Treatment with ocriplasmin (JETREA®) in the study eye at any time 6. Previous use of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN® or OZURDEX® IVT implants at any time 7. Intraocular pressure (IOP) =25 mm Hg in the study eye 8. History of glaucoma filtration surgery in the past Other Exclusion Criteria Apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides noninferior best-corrected visual acuity (BCVA) compared to 2 mg aflibercept dosed every 8 weeks;Secondary Objective: - To determine the effect of HD vs 2 mg aflibercept on anatomic and other visual measures of response - To evaluate the safety, immunogenicity and pharmacokinetics (PK) of HD;Primary end point(s): Change from baseline in best corrected visual acuity (BCVA) at week 48;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients without retinal fluid at the foveal center at week 12 2. Proportion of patients with a =2 step improvement in Diabetic Retinopathy Severity Scale (DRSS) at week 48 3. Change from baseline in BCVA at week 60 (region-specific analysis) 4. Proportion of patients gaining =15 letters at week 48 5. Proportion of patients with BCVA =69 letters at week 48 6. Proportion of patients without fluid at foveal center at week 48 7. Change from baseline in central retinal thickness (CRT) at week 48 8. Proportion of patients without leakage on fluorescein angiography (FA) at week 48 9. Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at week 48 10. Systemic pharmacokinetics of aflibercept as assessed from baseline through week 48 11. Assessment of immunogenicity to aflibercept through end of study (EOS) week (week 96) 12. Safety evaluation by assessment of adverse events (AEs) and serious adverse events (SAEs) through weeks 48, 60, and 96;Timepoint(s) of evaluation of this end point: 1: Week 12 2, 4-10: Week 48 3: Week 60 11: Week 96 12: Weeks 48, 60, 96 | — |
Countries
Canada, China, Czech Republic, Germany, Hungary, Japan, Russian Federation, United Kingdom, United States
Contacts
Public ContactClinical Trial Management
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed