Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

  • STATUS
    Recruiting
  • End date
    May 9, 2023
  • participants needed
    640
  • sponsor
    Regeneron Pharmaceuticals
Updated on 14 May 2021
Investigator
Clinical Trials Administrator
Primary Contact
Regeneron Study Site (7.5 mi away) Contact
+199 other location
swelling
retinopathy
diabetic retinopathy
corrected visual acuity
visual impairment
aflibercept
diabetic macular edema
diabetic eye disease

Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

  • To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
  • To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Details
Condition NIDDM, Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetic Macular Edema, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 1 diabetes mellitus, type 2 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Aflibercept, High-Dose aflibercept
Clinical Study IdentifierNCT04429503
SponsorRegeneron Pharmaceuticals
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diabetic macular edema (DME) with central involvement in the study eye
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
Willing and able to comply with clinic visits and study-related procedures
Provide informed consent signed by study participant or legally acceptable representative

Exclusion Criteria

Evidence of macular edema due to any cause other than diabetes mellitus in either eye
Active proliferative diabetic retinopathy in the study eye
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
Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time
Treatment with ocriplasmin (JETREA) in the study eye at any time
NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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