Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

Not Applicable

Withdrawn

• Conditions: Herpes Simplex Dendritic Keratitis
• Interventions: Other: Standard of Care; Device: Prokera Slim

• Registration Number: NCT04598282
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Study Start: 2021-01-21
• Primary Completion: 2021-10
• Study Completion: 2022-07-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Standard of Care	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).
Treatment Arm	Prokera Slim	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.

Primary Outcome Measures

Name	Time	Method
Time-dependent change in BCVA by 1 weeks	1 week	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

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

Trial Locations

Locations (1)

Casey Eye Institute, Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States