Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Bayer

Stanford Investigator(s):

Intervention(s):

  • Drug: aflibercept
  • Drug: High-dose aflibercept

Phase:

Phase 2/Phase 3

Eligibility


Key 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

Key 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting