Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis

Oregon Health & Science University (OHSU)

Status: Withdrawn

Conditions: Herpes Simplex Dendritic Keratitis

Treatments: Device: Prokera Slim; Other: Standard of Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04598282

IRB00021203

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

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).

Treatment:

Other: Standard of Care

Treatment Arm

Active Comparator group

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.

Treatment:

Device: Prokera Slim