Herpes Simplex Dendritic KeratitisNCT04598282
Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment in Herpes Simplex Dendritic Keratitis
A study testing Prokera Slim in people with Herpes Simplex Dendritic Keratitis, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Herpes Simplex Dendritic Keratitis
- What is being tested?
- Prokera Slim
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 28 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Pilot Study Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment for Primary or Recurrent Herpes Simplex Dendritic Keratitis
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.
Read the 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
- Being tested
- Prokera Slim, Standard of Care
- Keywords
- Prokera, Adjunctive Cryopreserved Amniotic Membrane, Prokera Slim
- Medical subject headings
- Keratitis, Dendritic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prokera SlimDevice
Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.
Standard of CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | 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). Receives: Other: Standard of Care |
| Treatment Arm | Active comparator | 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. Receives: Device: Prokera Slim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Secondary outcomes (9)
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)
Measured: 1 week
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).
Measured: 2 weeks
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).
Measured: 2 months
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+.
Measured: 2 months
Proportion of patients with recurrence by 2 months
Proportion of patients with recurrence by 2 months counted individually
Measured: 2 months
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.
Measured: 2 months
Change in conjunctival inflammation at 1 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Measured: 1 week
Change in conjunctival inflammation at 2 week
Conjunctival inflammation graded by investigator as none (0), mild (1), moderate (2), and severe (3)
Measured: 2 week
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
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Jan 2021
- Primary completionOct 2021 (estimated)
- Study completion28 Jul 2022
Why it stopped: No patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Dendritic KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- BioTissue Holdings, Inc
- Responsible party
- Principal investigator, Richard Stutzman, MD, Oregon Health and Science University
- Investigators
- Richard Stutzman, M.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598282
- Sponsor's protocol ID
- IRB00021203
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2020
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Share EPD once available
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Adjunctive Cryopreserved Amniotic Membrane Treatment for Primary or Recurrent Herpes Simplex Dendritic Keratitis
- ClinicalTrials.gov ID
- NCT04598282
- Acronym / sponsor ID
- IRB00021203
- Conditions
- Herpes Simplex Dendritic Keratitis
- Keywords
- Prokera, Adjunctive Cryopreserved Amniotic Membrane, Prokera Slim
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- BioTissue Holdings, Inc
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: Standard of CareAll 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 | Active comparator | Device: Prokera SlimAll 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prokera SlimPlacement of an Adjunctive Cryopreserved Amniotic Membrane Treatment. | Device | Treatment Arm |
| Standard of CareStandard 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). | Other | Control Arm |
Primary outcome
Time-dependent change in BCVA by 1 weeks
Time frame: 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).
9 secondary outcomes
Proportion of patients with complete epithelialization by 1 week
Time frame: 1 week
Time-dependent change in BCVA by 2 weeks
Time frame: 2 weeks
Time-dependent change in BCVA by 2 months
Time frame: 2 months
Proportion of patients with corneal opacity at 2 months
Time frame: 2 months
Proportion of patients with recurrence by 2 months
Time frame: 2 months
Change in corneal sensitivity from baseline to 2 months
Time frame: 2 months
Change in conjunctival inflammation at 1 week
Time frame: 1 week
Change in conjunctival inflammation at 2 week
Time frame: 2 week
Total number of extra patient visits, treatments, and procedures throughout study
Time frame: 2-3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Yes. Share EPD once available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Stutzman, M.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prokera Slim in people with Herpes Simplex Dendritic Keratitis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-dependent change in BCVA by 1 weeks (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.