Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

NCT ID: NCT04598282

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2022-07-28

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.

Conditions

Herpes Simplex Dendritic Keratitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: ACTIVE_COMPARATOR

Prokera Slim

Intervention Type: DEVICE

Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.

Control Arm

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).

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: 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).

Interventions

Prokera Slim

Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.

Intervention Type: DEVICE

Standard of Care

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioTissue Holdings, Inc

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Richard Stutzman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Stutzman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00021203

Identifier Type: -

Identifier Source: org_study_id