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Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

Primary Purpose

Herpes Simplex Dendritic Keratitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prokera Slim
Standard of Care
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex Dendritic Keratitis focused on measuring Prokera, Adjunctive Cryopreserved Amniotic Membrane, Prokera Slim

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Clinical signs of a cause other than herpes simplex virus
  2. Presence of corneal ulcer with or without microbial infection
  3. Lid surface abnormalities or conjunctival scarring that affect lid function in either eye
  4. Atopic disease
  5. History of penetrating keratoplasty
  6. Active stromal keratitis or iritis
  7. 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)
  8. Ocular surface malignancy
  9. History of recent ocular surgery/trauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK
  10. A medical or ocular condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
  11. Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
  12. Not capable of providing informed consent

Sites / Locations

  • Casey Eye Institute, Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Arm

Treatment Arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of patients with complete epithelialization by 1 week
Proportion of patients with complete epithelialization by 1 week, graded 0, SPK 1+, SPK 2+, SPK 3+ (SPK is Superficial Punctate Keratitis)
Time-dependent change in BCVA by 2 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).
Time-dependent change in BCVA by 2 months
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).
Proportion of patients with corneal opacity at 2 months
Proportion of patients with corneal opacity at 2 months, graded 0, 1+, 2+, 3+, and 4+.
Proportion of patients with recurrence by 2 months
Proportion of patients with recurrence by 2 months counted individually
Change in corneal sensitivity from baseline to 2 months
Change in corneal sensitivity from baseline to 2 months using Cochet-Bonnet esthesiometer, graded 0/4, 1/4, 2/4, 3/4, and 4/4.
Change in conjunctival inflammation at 1 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Change in conjunctival inflammation at 2 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Total number of extra patient visits, treatments, and procedures throughout study
Total number of extra patient visits, treatments, and procedures throughout study, counted individually by type

Full Information

First Posted
October 16, 2020
Last Updated
September 19, 2022
Sponsor
Oregon Health and Science University
Collaborators
Tissue Tech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04598282
Brief Title
Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis
Official Title
A Pilot Study Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment for Primary or Recurrent Herpes Simplex Dendritic Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No patient enrollment
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Tissue Tech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cryopreserved amniotic membrane (AM) contains anti-inflammatory, anti-scarring and antiangiogenic effects known in treating many ocular surface diseases. This notion is further strengthened by many studies showing that amniotic membrane can effectively control inflammation in HSV stromal keratitis in a murine model of HSV necrotizing keratitis and surgical application in ~7 human studies of epithelial and stromal HSV keratitis with or without an adjuvant antiviral therapy. More importantly, PROKERA SLIM in conjunction with oral acyclovir has been shown to facilitate the ease of early intervention to accelerate restoration in herpetic keratitis in 2 case series of 5 eyes. However, a formal prospective study has not been performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex Dendritic Keratitis
Keywords
Prokera, Adjunctive Cryopreserved Amniotic Membrane, Prokera Slim

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Prokera Slim
Intervention Description
Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Time-dependent change in BCVA by 1 weeks
Description
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).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Proportion of patients with complete epithelialization by 1 week
Description
Proportion of patients with complete epithelialization by 1 week, graded 0, SPK 1+, SPK 2+, SPK 3+ (SPK is Superficial Punctate Keratitis)
Time Frame
1 week
Title
Time-dependent change in BCVA by 2 weeks
Description
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).
Time Frame
2 weeks
Title
Time-dependent change in BCVA by 2 months
Description
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).
Time Frame
2 months
Title
Proportion of patients with corneal opacity at 2 months
Description
Proportion of patients with corneal opacity at 2 months, graded 0, 1+, 2+, 3+, and 4+.
Time Frame
2 months
Title
Proportion of patients with recurrence by 2 months
Description
Proportion of patients with recurrence by 2 months counted individually
Time Frame
2 months
Title
Change in corneal sensitivity from baseline to 2 months
Description
Change in corneal sensitivity from baseline to 2 months using Cochet-Bonnet esthesiometer, graded 0/4, 1/4, 2/4, 3/4, and 4/4.
Time Frame
2 months
Title
Change in conjunctival inflammation at 1 week
Description
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Time Frame
1 week
Title
Change in conjunctival inflammation at 2 week
Description
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Time Frame
2 week
Title
Total number of extra patient visits, treatments, and procedures throughout study
Description
Total number of extra patient visits, treatments, and procedures throughout study, counted individually by type
Time Frame
2-3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Stutzman, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey Eye Institute, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Share EPD once available
IPD Sharing Time Frame
1 year

Learn more about this trial

Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

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