Clinical trial NCT04598282: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Herpes Simplex Dendritic Keratitis
Keywords: Prokera
Adjunctive Cryopreserved Amniotic Membrane
Prokera Slim
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: BioTissue Holdings, Inc
First posted: 2020-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time-dependent change in BCVA by 1 weeks
timeFrame: 1 week
Secondary outcomes:
measure: Proportion of patients with complete epithelialization by 1 week
timeFrame: 1 week
measure: Time-dependent change in BCVA by 2 weeks
timeFrame: 2 weeks
measure: Time-dependent change in BCVA by 2 months
timeFrame: 2 months
measure: Proportion of patients with corneal opacity at 2 months
timeFrame: 2 months
measure: Proportion of patients with recurrence by 2 months
timeFrame: 2 months
measure: Change in corneal sensitivity from baseline to 2 months
timeFrame: 2 months
measure: Change in conjunctival inflammation at 1 week
timeFrame: 1 week
measure: Change in conjunctival inflammation at 2 week
timeFrame: 2 week
measure: Total number of extra patient visits, treatments, and procedures throughout study
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Casey Eye Institute, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Richard Stutzman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: