Principal Investigator: Rachael Jacoby
Keywords: Diabetic eye disease , Investigational treatment Department: Ophthalmology-Services
IRB Number: 00088332 Co Investigator:  
Specialty: Ophthalmology
Sub Specialties: Diabetic Retinopathy
Recruitment Status: Active, not recruiting

Contact Information

Kara Halsey

Brief Summary

The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).
The secondary objectives of the study are:
  • To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
  • To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of diabetic macular edema (DME)
  • To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR.

Inclusion Criteria

1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the central reading center, in whom PRP can be safely deferred for at least 6 months per the investigator

2. BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria

1. Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye

2. Evidence of retinal neovascularization on clinical examination or FA

3. Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or any prior PRP in the study eye

4. Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye

5. Any prior intraocular steroid injection in the study eye

6. History of vitreoretinal surgery in the study eye

7. Intraocular pressure (IOP) ≥25 mm Hg in the study eye

8. Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye

9. Any intraocular inflammation or infection in either eye within 3 months of the screening visit

10. Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye

11. Ocular media of insufficient quality to obtain fundus and optical coherence tomography

(OCT) images in the study eye

12. Hemoglobin A1c (HbA1c) >12%, or if HbA1c is ≤12%, diabetes mellitus is uncontrolled in the opinion of the investigator

13. Uncontrolled blood pressure (defined as systolic >160 mm Hg or diastolic >95 mm Hg while patient is sitting)

14. History of cerebrovascular accident or myocardial infarction within 180 days of day 1

15. Renal failure, dialysis, or history of renal transplant

16. Women who are breastfeeding or who have a positive serum hCG/urine pregnancy test at the screening or baseline visit

17. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety

18. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications

19. Participation as a patient in any interventional clinical study within the 12 weeks prior to day 1 of the study

20. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; 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 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

21. Patients who are on systemic anti-VEGF treatment (ie, bevacizumab, ziv-aflibercept) for oncology treatment (if a patient requires systemic anti-VEGF treatment during the study, the patient will be withdrawn)