Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

• Status: Completed
• Trial end date: 2021-04-09
• Target enrollment: 0
• Participant gender: All

Summary

The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Greater Houston Retina Research
• Collaborators: Regeneron Pharmaceuticals; The Cleveland Clinic
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

1. Men or Women > 18 years of age with type 1 or II diabetes mellitus

2. Diabetic Retinopathy, DRSS Level 47A to 71A, as assessed by CRC (enrollment of PDR levels will be limited to 50% of the total population)

3. BCVA in the study eye better than 20/800

Exclusion Criteria:

1. Any prior systemic anti-VEGF treatment or IVT anti-search vascular endothelial growth factor (VEGF) treatment in the study eye within 24 weeks of screening/baseline

2. Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of screening/baseline

3. Any prior treatment with Ozurdex or Iluvien in the study eye

4. SD-OCT central subfield thickness (CST) > 320 µm in the study eye

5. Central DME causing visual acuity loss, in which treatment can not be safely deferred for at least 6 months, in the investigator's judgment

6. Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage is allowed as long as DRSS level is 71A or lower.

7. History of panretinal photocoagulation (PRP) in the study eye

8. History of vitrectomy surgery in the study eye

9. Cataract surgery in the study eye within 8 weeks of screening/baseline

10. Pregnant or breast-feeding women

11. Sexually active men* or women of childbearing potential** who are unwilling to practiceadequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

• Contraception is not required for men with documented vasectomy.

** Postmenopausal women must be amenorrheic for at least 52 weeks in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

12. If currently receiving diaylisis, must have started treatment more than 12 weeks prior to screening/baseline

13. Uncontrolled blood pressure (defined as > 190/110 mm Hg systolic/diastolic, while seated)