Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

NCT02600429 | Terminated Phase 3 Results

• 1 other identifier: RGN-NK-301
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 11

Brief Summary

The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic Solution compared to placebo for the treatment of NK.

Conditions

Neurotrophic Keratopathy

Keywords

Neurotrophic Keratopathy; NK

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Achieving Complete Healing at Day 29.

  Percentage of subjects achieving complete healing of the persistent epithelial defect as determined by corneal fluorescein staining at day 29 after first dosing.

  29 days after first dosing

Secondary Outcomes (5)

• Percentage of Subjects Achieving Complete Healing at 8, 15, 22, 36, 43 Days

  8, 15, 22, 36, 43 days after first dosing

• Epithelial Defect Measurement and Classification as Stage 1, 2 or 3 Using Mackie Classification.

  8, 15, 22, 29, 36, 43 days after first dosing

• Tear Film Break-up Time at 29, 36, 43 Days

  29, 36, 43 days after first dosing

• Ocular Discomfort by Questionnaire at 8, 15, 22, 29, 36, 43 Days After First Dosing

  8, 15, 22, 29, 36, 43 days after first dosing

• Visual Acuity(logMAR) at 8, 15, 22, 29, 36, 43 Days

  8, 15, 22, 29, 36, 43 days after first dosing

Other Outcomes (4)

• The Number of Participants With an Abnormal Findings by Slit-lamp Biomicroscopy at 8, 15, 22, 29, 36, 43 Days

  8, 15, 22, 29, 36, 43 days after first dosing

• Corneal Sensitivity Using the Aesthesiometer (Cochet-Bonnet)

  29, 43 days after first dosing

• The Number of Participants With an Abnormal Findings by Dilated Fundoscopy at 29, 43 Days

  29, 43 days after first dosing

Study Arms (2)

RGN-259

EXPERIMENTAL

It is a preservative-free, sterile eye drop solution containing Tβ4

Drug: RGN-259

Placebo

PLACEBO COMPARATOR

It is composed of the same excipients as RGN-259 but does not contain Tβ4.

Drug: Placebo

Interventions

RGN-259 DRUG

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.

Also known as: Tβ4

RGN-259

Placebo DRUG

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Also known as: Vehicle Control

Placebo

Eligibility Criteria

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

You may qualify if:

• Be male or female of any race, at least 18 years of age
• Have provided verbal and written informed consent.
• Be able and willing to follow instructions, including participation in all study assessments and visits;
• Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use an adequate method of birth control throughout the study period.

You may not qualify if:

• Have any clinically significant slit lamp findings at Visit 1 that in the opinion of the investigator may interfere with the study parameters;
• Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergy that requires treatment
• Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the investigator, is the primary cause of the persistent epithelial defect;
• Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active inflammation (e.g. follicular conjunctivitis) not related to NK
• Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the study;
• Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior to Visit 1 or anticipates use of contact lenses during the study period;
• Have an uncontrolled systemic disease that in the opinion of the investigator may interfere with the study parameters;
• Anticipate a change in immunosuppressive therapy during the course of the study;

Sponsors & Collaborators

• ReGenTree, LLC: lead

Study Sites (11)

Hull Eye Center

Lancaster, California, 93534, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Eye Center of Northern Colorado

Fort Collins, Colorado, 80525, United States

Location

Insight Vision Group

Parker, Colorado, 80134, United States

Location

Medical Faculty Associates, Inc.

Washington D.C., District of Columbia, 20037, United States

Location

Midwest Cornea Associates, LLC

Indianapolis, Indiana, 46290, United States

Location

Koffler Vision Group

Lexington, Kentucky, 40509, United States

Location

Richard Eiferman, MD, PSC

Louisville, Kentucky, 40205, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Results Point of Contact

• Title: Director of clinical operation
• Organization: clinical operation

swkang@regentreellc.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 9, 2015
• Study Start: September 17, 2015
• Primary Completion: November 20, 2019
• Study Completion: March 9, 2020
• Last Updated: August 30, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)