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Trial record 1 of 1 for:    NCT05409235
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OTT166 in Diabetic Retinopathy (DR)

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ClinicalTrials.gov Identifier: NCT05409235
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
OcuTerra Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: OTT166 Drug: Vehicle control Phase 2

Detailed Description:

This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) and participants who do not have center-involved diabetic macular edema (CI-DME) will be randomized into the following groups:

OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)
Actual Study Start Date : July 29, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTT166 Cohort 1
Participants will receive OTT166 low dose for 24 weeks
Drug: OTT166
Participants will receive OTT166 ophthalmic solution

Experimental: OTT166 Cohort 2
Participants will receive OTT166 high dose for 24 weeks
Drug: OTT166
Participants will receive OTT166 ophthalmic solution

Placebo Comparator: Vehicle control Cohort 1
Participants will receive vehicle control for 24 weeks
Drug: Vehicle control
Participants will receive vehicle control

Placebo Comparator: Vehicle control Cohort 2
Participants will receive vehicle control for 24 weeks
Drug: Vehicle control
Participants will receive vehicle control




Primary Outcome Measures :
  1. Proportion of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Upto end of the study (Week 24) ]
    To characterize the safety of topical OTT166 in participants with DR.

  2. Proportion of participants who have improved by ≥ 2 steps from baseline in Diabetic Retinopathy Severity Scale (DRSS) scores [ Time Frame: At week 24 ]
    To characterize the efficacy of topical OTT166 in participants with DR. Difference between treatments in proportion of participants achieving ≥ 2 steps improvement from baseline as determined by central reading center assessment using the DRSS will be assessed. Greater DR scores confer a greater chance of converting to PDR. Higher scores are also associated with decreased vision-related quality of life measures.


Secondary Outcome Measures :
  1. Proportion of participants developing worse than mild PDR (DRSS 65 and above) [ Time Frame: At week 24 ]
    To determine if topical OTT166 will prevent or delay the occurrence of visually threatening complications (VTC). VTC is defined as the composite outcome of PDR (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and/or anterior segment neovascularization (ASNV) (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle) and/or center-involved diabetic macular edema (CI-DME).

  2. Proportion of participants who develop ASNV [ Time Frame: At week 24 ]
    To determine if topical OTT166 will prevent or delay the occurrence of VTC. VTC is defined as the composite outcome of PDR (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and/or ASNV (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle) and/or CI-DME.

  3. Time to development of PDR worse than mild (DRSS 65 and above) [ Time Frame: At week 24 ]
    To determine if topical OTT166 will prevent or delay the occurrence of VTC. VTC is defined as the composite outcome of PDR (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and/or ASNV (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle) and/or CI-DME. Time to develop PDR worse than mild (DRSS 65 and above) will be assessed.

  4. Proportion of participants who develop CI-DME [ Time Frame: At week 24 ]
    To determine if topical OTT166 will prevent or delay the occurrence of VTC. VTC is defined as the composite outcome of PDR (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and/or ASNV (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle) and/or CI-DME.

  5. Time to development of CI-DME [ Time Frame: At week 24 ]
    To determine if topical OTT166 will prevent or delay the occurrence of VTC. VTC is defined as the composite outcome of PDR (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and/or ASNV (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle) and/or CI-DME. Time to develop CI-DME will be assessed.

  6. Proportion of participants with change in DRSS steps [ Time Frame: At week 24 ]
    To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166. Change in DRSS steps is defined as DR worsening or improving by 1, 2, or ≥ 3 steps.

  7. Proportion of participants with mild PDR (DRSS score 61) at baseline who regress to NPDR (DRSS score ≤ 53) [ Time Frame: At week 24 ]
    To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166.

  8. Change from baseline in DRSS step [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166. Change in DRSS steps is defined as DR worsening or improving by 1, 2, or ≥ 3 steps.

  9. Change from baseline in best corrected visual acuity (BCVA) [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA will be assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. A higher score represents better functioning.

  10. Proportion of participants with lines gained/lost of BCVA [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. Proportion of participants who gained/lost lines of BCVA (± 5, 10, and 15 ETDRS letters) will be assessed.

  11. Area under the curve (AUC) for change from baseline in BCVA [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA will be assessed by ETDRS letters score. A higher score represents better functioning.

  12. Change from baseline in central subfield thickness (CST) [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST will be assessed by optical coherence tomography (OCT).

  13. AUC for change from baseline in CST [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST will be assessed by OCT.

  14. Proportion of participants who met the rescue criteria [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR.

  15. Time to meet rescue therapy criteria [ Time Frame: From Baseline (Day 1) up to Week 24 ]
    To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR. Time required to meet rescue therapy criteria will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05409235


Contacts
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Contact: Susannah Sinozich 617-701-7382 DREAM@ocuterratx.com
Contact: Majid Anderesi, MD

Locations
Show Show 53 study locations
Sponsors and Collaborators
OcuTerra Therapeutics, Inc.
Parexel
Investigators
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Principal Investigator: Carl Regillo, MD Principal Investigator
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Responsible Party: OcuTerra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05409235    
Other Study ID Numbers: OTT166-201
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OcuTerra Therapeutics, Inc.:
Diabetic Retinopathy
Ophthalmic solution
Non-proliferative diabetic retinopathy
Proliferative diabetic retinopathy
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases