OTT166 in Diabetic Retinopathy (DR)

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.

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

Details

• Lead Sponsor: OcuTerra Therapeutics, Inc.
• Collaborator: Parexel

Criteria

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], or mild PDR [DRSS level 61]

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

3. Treatment-naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser within 1,000 μm diameter of the foveal center/treatment for macular edema or DR in the study eye)

Exclusion Criteria:

1. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye

2. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye

3. Eyes with DRSS score 61 due to fibrous proliferations at disc or fibrous proliferations elsewhere

4. Any prior systemic anti-VEGF intravitreal injection (IVT) or anti-VEGF treatment in the study eye

5. Any prior intraocular steroid injection in the study eye

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

7. Uncontrolled glaucoma or ocular hypertension in the study eye

8. Hypertension

9. Screening HbA1c blood test > 10.0%

10. Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant

11. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory

12. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months

13. Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye

14. Previous pars plana vitrectomy in the study eye

15. Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment

16. Yttrium Aluminum Garnet (YAG) laser treatment in the study eye within 90 days prior to study enrollment

17. Concomitant use of any topical ophthalmic medications in the study eye

18. Contact lens use from time of screening throughout the study

19. Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome

20. Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision

21. Chronic or recurrent uveitis in the study eye

22. Ongoing ocular infection or inflammation in either eye

23. A history of cataract surgery complicated by vitreous loss in the study eye

24. Congenital eye malformations in the study eye

25. A history of penetrating ocular trauma in the study eye

26. Cognitive impairment

27. Women who are breastfeeding or who have a positive serum human chorionic gonadotropin (hCG)/urine pregnancy test at the screening or Baseline (BL) Visit

28. Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and optical coherence tomography (OCT) images in the study eye

29. CST of > 300 μm