Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

NCT05409235 | Completed Phase 2 Results FDA Drug

• 1 other identifier: OTT166-201
• Study Type: interventional
• Target: 225
• Locations: 2 countries
• Sites: 68

Brief Summary

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

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy; Ophthalmic solution; Non-proliferative diabetic retinopathy; Proliferative diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores

  To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.

  At week 24

Secondary Outcomes (17)

• Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)

  At week 24

• Proportion of Participants Who Developed ASNV

  At week 24

• Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)

  At week 24

• Proportion of Participants Who Developed CI-DME

  At week 24

• The Development of CI-DME

  At week 24

Other Outcomes (2)

• Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline

  24 weeks

• Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53

  24 weeks

Study Arms (4)

OTT166 Cohort 1

EXPERIMENTAL

Participants will receive OTT166 5% twice a day (BID) for 24 weeks

Drug: OTT166

OTT166 Cohort 2

EXPERIMENTAL

Participants will receive OTT166 5% four times a day (QID) for 24 weeks

Drug: OTT166

Vehicle control Cohort 1

PLACEBO COMPARATOR

Participants will receive vehicle control BID for 24 weeks

Drug: Vehicle control

Vehicle control Cohort 2

PLACEBO COMPARATOR

Participants will receive vehicle control QID for 24 weeks

Drug: Vehicle control

Interventions

OTT166 DRUG

Participants will receive OTT166 ophthalmic solution

Also known as: nesvategrast

OTT166 Cohort 1; OTT166 Cohort 2

Vehicle control DRUG

Participants will receive vehicle control

Vehicle control Cohort 1; Vehicle control Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[DRSS level 61\] NVE \< 0.5 DA in 1 + quadrants\], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator
• 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)
• Willing and able to return for all study visits and comply with study-related procedures
• Able to adhere to the study dosing requirements
• Understands and signs the written Informed Consent Form

You may not qualify if:

• CST of \> 325 μm
• a. Fluid in the central subfield is allowed so long as CST is ≤325 μm and there is a normal foveal contour as determined by the Central Reading Center
• Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)
• Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
• Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed
• 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 defined as an IOP \> 25 mmHg regardless of concomitant treatment with IOP-lowering medications
• Hypertension defined as systolic \> 180 mmHg or \> 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic \> 100 mmHg
• 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 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 participant at high risk for treatment complications
• 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 as determined to be significant by the Investigator
• Previous pars plana vitrectomy in the study eye
• Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment

Sponsors & Collaborators

• OcuTerra Therapeutics, Inc.: lead
• Parexel: collaborator

Study Sites (68)

Clinical Site 123

Peoria, Arizona, 85381, United States

Location

Clinical Site 150

Phoenix, Arizona, 85021, United States

Location

Clinical Site 111

Beverly Hills, California, 90211, United States

Location

Clinical Site 113

Encino, California, 91436, United States

Location

Clinical Site 138

Fresno, California, 93720, United States

Location

Clinical Site 129

Huntington Beach, California, 92647, United States

Location

Clinical Site 121

Pasadena, California, 91105, United States

Location

Clinical Site 127

Pasadena, California, 91107, United States

Location

Clinical Site 142

Rancho Cordova, California, 95670, United States

Location

Clinical Site 116

Riverside, California, 92505, United States

Location

Clinical Site 125

Sacramento, California, 95841, United States

Location

CinCor Site 171

Torrance, California, 90505, United States

Location

Clinical Site 160

Walnut Creek, California, 94598-5910, United States

Location

Clinical Site 157

Coral Springs, Florida, 33067, United States

Location

Clinical Site 106

Fort Lauderdale, Florida, 33309, United States

Location

Clinical Site 131

Jacksonville, Florida, 32216, United States

Location

Clinical Site 110

Miami, Florida, 33143, United States

Location

Clinical Site 153

St. Petersburg, Florida, 33711-1141, United States

Location

Clinical Site 117

Winter Haven, Florida, 33880, United States

Location

Clinical Site 112

‘Aiea, Hawaii, 96701, United States

Location

Clinical Site 146

Oak Forest, Illinois, 60452, United States

Location

Clinical Site 128

Springfield, Illinois, 62704, United States

Location

Clinical Site 154

Indianapolis, Indiana, 46290-1166, United States

Location

Clinical Site 139

Lenexa, Kansas, 66215, United States

Location

Clinical Site 166

Louisville, Kentucky, 40206, United States

Location

Clinical Site 167

Metairie, Louisiana, 70006, United States

Location

Clinical Site 163

Baltimore, Maryland, 21237, United States

Location

Clinical Site 145

Baltimore, Maryland, 21287, United States

Location

Clinical Site 103

Hagerstown, Maryland, 21740, United States

Location

Clinical Site 151

Boston, Massachusetts, 02111, United States

Location

Clinical Site 104

Boston, Massachusetts, 02114, United States

Location

Clinical Site 141

Detroit, Michigan, 48201, United States

Location

Clinical Site 155

Southaven, Mississippi, 38671, United States

Location

Clinical Site 101

Reno, Nevada, 89502, United States

Location

Clinical Site 105

Bloomfield, New Jersey, 07003, United States

Location

Clinical Site 136

Cherry Hill, New Jersey, 08034, United States

Location

Clinical Site 114

Teaneck, New Jersey, 07666, United States

Location

Clinical Site 118

Albuquerque, New Mexico, 87109, United States

Location

Clinical Site 109

Liverpool, New York, 13088, United States

Location

Clinical Site 162

Rochester, New York, 14618, United States

Location

Clinical Site 165

Raleigh, North Carolina, 27587, United States

Location

Clinical Site 143

Beachwood, Ohio, 44122, United States

Location

Clinical Site 120

Cleveland, Ohio, 44122, United States

Location

Clinical Site 152

Dublin, Ohio, 43016, United States

Location

Clinical Site 122

Edmond, Oklahoma, 73013, United States

Location

Clinical Site 135

Portland, Oregon, 97239, United States

Location

Clinical Site 158

Springfield, Oregon, 97477, United States

Location

Clinical Site 115

Kingston, Pennsylvania, 18704, United States

Location

Clinical Site 130

Beaufort, South Carolina, 29902, United States

Location

Clinical Site 133

Rapid City, South Dakota, 57701, United States

Location

Clinical Site 168

Germantown, Tennessee, 38138, United States

Location

Clinical Site 164

Knoxville, Tennessee, 37909-2686, United States

Location

Clinical Site 169

Memphis, Tennessee, 38119, United States

Location

Clinical Site 119

Nashville, Tennessee, 37203, United States

Location

Clinical Site 161

Austin, Texas, 78705, United States

Location

Clinical Site 102

Bellaire, Texas, 77401, United States

Location

Clinical Site 108

Bellaire, Texas, 77401, United States

Location

Clinical Site 147

Burleson, Texas, 76028, United States

Location

Clinical Site 132

Fort Worth, Texas, 76104, United States

Location

Clinical Site 156

Houston, Texas, 77025, United States

Location

Clinical Site 126

McAllen, Texas, 78503, United States

Location

Clinical Site 140

San Antonio, Texas, 78240-1375, United States

Location

Clinical Site 137

San Antonio, Texas, 78240, United States

Location

Clinical Site 144

Texas City, Texas, 78240, United States

Location

Clinical Site 159

Lynchburg, Virginia, 24502, United States

Location

Clinical Site 149

Seattle, Washington, 98125, United States

Location

Clinical Site 148

Spokane, Washington, 98204, United States

Location

Clinical Site 201

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Limitations and Caveats

\[Not specified\]

Results Point of Contact

• Title: D. Scott Edwards, Ph.D.
• Organization: Chief Development Officer

sedwards@ocuterratx.com

(339) 234-1333

Study Officials

• Carl Regillo, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: July 29, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (67); PR (1)