NCT05393284

Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

Active, enrolled Phase 2 Last updated 14 June 2024

What this trial tests

Phase 2 trial testing OPL-0401 Dose 1 in Non-proliferative Diabetic Retinopathy in 114 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 August 2022

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	Valo Health, Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	114
Start date	16 August 2022
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	25 locations across United States

Drugs / interventions tested

• OPL-0401 Dose 1 — full drug profile →
• Placebo

Conditions studied

• Non-proliferative Diabetic Retinopathy — all drugs for Non-proliferative Diabetic Retinopathy →
• Proliferative Diabetic Retinopathy — all drugs for Proliferative Diabetic Retinopathy →

Sponsor

Valo Health, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-proliferative Diabetic Retinopathy or Proliferative Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Improvement in Diabetic Retinopathy Severity Scale (DRSS) score
  Time frame: 24 weeks/168 days
  Proportion of patients with a ≥2-step improvement from baseline in DRSS

Sponsor's own description

OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diabetic vascular diseases: molecular mechanisms and therapeutic strategies.
   Li Y, Liu Y, Liu S, Gao M, et al · · 2023 · cited 392× · PMID 37037849 · DOI 10.1038/s41392-023-01400-z
2. Beyond VEGF: Targeting Inflammation and Other Pathways for Treatment of Retinal Disease.
   Muniyandi A, Hartman GD, Song Y, Mijit M, et al · · 2023 · cited 28× · PMID 37142441 · DOI 10.1124/jpet.122.001563
3. The changing scenario of drug discovery using AI to deep learning: Recent advancement, success stories, collaborations, and challenges.
   Chakraborty C, Bhattacharya M, Lee SS, Wen ZH, et al · · 2024 · cited 25× · PMID 39257717 · DOI 10.1016/j.omtn.2024.102295
4. New targets in diabetic retinopathy: addressing limitations of current treatments through the Sema3A/Nrp1 pathway.
   Sivaprasad S, Cheung CMG, Gliem M, Wykoff CC, et al · · 2025 · cited 1× · PMID 40634736 · DOI 10.1038/s41433-025-03835-w
5. Ocular gene therapy as a sustained drug delivery system: pharmacokinetic and genokinetic perspectives.
   Leferman CE, Ciubotaru AD. · · 2025 · PMID 41532047 · DOI 10.25122/jml-2025-0180