Open Actively Recruiting

OTT166 in Diabetic Retinopathy (DR)


Brief Summary

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

Primary Purpose
Study Type
Phase 2


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

  • 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]
  • BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
  • Normal foveal contour
  • Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)

Exclusion Criteria:

  • CST of > 325 μm
  • Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
  • Eyes with DRSS score 61 due to fibrous proliferations at disc or fibrous proliferations elsewhere
  • Any prior systemic anti-VEGF intravitreal injection (IVT) or anti-VEGF treatment in the study eye
  • Any prior intraocular steroid injection in the study eye
  • Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
  • Uncontrolled glaucoma or ocular hypertension in the study eye
  • Hypertension
  • Screening HbA1c blood test > 12.0%
  • Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory
  • 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
  • Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye
  • Previous pars plana vitrectomy in the study eye
  • Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment
  • Yttrium Aluminum Garnet (YAG) laser treatment in the study eye within 90 days prior to study enrollment
  • Concomitant use of any topical ophthalmic medications in the study eye
  • Contact lens use from time of screening throughout the study
  • Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome
  • Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision
  • Chronic or recurrent uveitis in the study eye
  • Ongoing ocular infection or inflammation in either eye
  • A history of cataract surgery complicated by vitreous loss in the study eye
  • Congenital eye malformations in the study eye
  • A history of penetrating ocular trauma in the study eye
  • Cognitive impairment
  • Women who are breastfeeding or who have a positive serum human chorionic gonadotropin (hCG)/urine pregnancy test at the screening or Baseline (BL) Visit
  • Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and optical coherence tomography (OCT) images in the study eye
  • Concomitant use of Semaglutide (Wegovy™, Ozempic®, Rybelsus®) or Thiazolidinediones (Actos®, Avandia®) within 12 months prior to Visit 1 (allowed if a stable dose has been established for at least 1 year of use)

Join this Trial

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Study Stats
Protocol No.
Endocrine and Metabolic Disorders
Eye/Ocular Disorders
Mayra Raygoza
  • UCLA Pasadena
For Providers
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