Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

NCT04598282 | Withdrawn FDA Device

• 1 other identifier: IRB00021203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To prospectively evaluate the effectiveness of Prokera Slim in adults with primary or recurrent herpetic epithelial keratitis in terms of visual function, corneal opacity, time to resolution, cost of care, number of patient visits.

Conditions

Herpes Simplex Dendritic Keratitis

Keywords

Prokera; Adjunctive Cryopreserved Amniotic Membrane; Prokera Slim

Outcome Measures

Primary Outcomes (1)

• Time-dependent change in BCVA by 1 weeks

  The BSCVA was recorded at 4 meters by a refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).

  1 week

Secondary Outcomes (9)

• Proportion of patients with complete epithelialization by 1 week

  1 week

• Time-dependent change in BCVA by 2 weeks

  2 weeks

• Time-dependent change in BCVA by 2 months

  2 months

• Proportion of patients with corneal opacity at 2 months

  2 months

• Proportion of patients with recurrence by 2 months

  2 months

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID (four times daily) for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion).

Other: Standard of Care

Treatment Arm

ACTIVE COMPARATOR

All subjects enrolled in the study will receive the standard of care that includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion). The treatment arm will also receive the placement of PROKERA SLIM for 5-7 days. A second PROKERA SLIM may be applied based on investigator's discretion. For patients with bilateral involvement only the worse eye will be enrolled for the treatment arm.

Device: Prokera Slim

Interventions

Prokera Slim DEVICE

Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.

Treatment Arm

Standard of Care OTHER

Standard of care includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion).

Control Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject (male or female) is at least 18 years of age.
• The subject is presenting with primary or recurrent herpetic dendritic epithelial keratitis based on investigator judgement
• The subject is presenting with acute (within 30 days) herpetic dendritic epithelial keratitis
• The subject is willing to comply with all study procedures and is able to consent.

You may not qualify if:

• Clinical signs of a cause other than herpes simplex virus
• Presence of corneal ulcer with or without microbial infection
• Lid surface abnormalities or conjunctival scarring that affect lid function in either eye
• Atopic disease
• History of penetrating keratoplasty
• Active stromal keratitis or iritis
• Presence of systemic or ocular infection or inflammation that is not related to herpes simplex virus (such as Sarcoidosis, Cogan syndrome, atopy, Lyme disease, Syphilis, mumps, Epstein-Barr virus)
• Ocular surface malignancy
• History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
• A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
• Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
• Not capable of providing informed consent

Sponsors & Collaborators

• Oregon Health and Science University: lead
• BioTissue Holdings, Inc: collaborator

Study Sites (1)

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Keratitis, Dendritic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Keratitis, Herpetic; Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Richard Stutzman, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: January 21, 2021
• Primary Completion: October 1, 2021
• Study Completion: July 28, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year

Locations

US (1)