Clinical trial NCT04850313: Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Official title: A Prospective, Randomized, Controlled Clinical Study to Evaluate the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bacterial Corneal Ulcer
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1: This phase will establish baseline characteristics for each patient that is randomized into the treatment arm for the phase 2 part of the study.

Phase 2: This phase will test the intervention of using ProKera Plus® versus continuing conventional treatment for the corneal ulcer
Primary purpose: TREATMENT

Brief summary: The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.

Detailed description: Bacterial keratitis is a serious bacterial infection of the cornea, usually caused by a persistent epithelial defect or ulcer that can lead to permanent vision loss from corneal scarring, perforation or endophthalmitis. An infectious corneal ulcer requires immediate treatment with intensive topical fortified broad-spectrum antibiotics to try to eliminate the pathogen. Corneal tissue destruction can be caused directly by infectious agents, the associated inflammatory response, or by ocular toxicity from frequent dosing of fortified antibiotics.1 Sutured amniotic membrane transplantation (AMT) has been shown to reduce pain and promote healing in human bacterial keratitis.2 ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface. ProKera Plus® contains a double layer of CryoTek amniotic membrane tissue to provide extra therapeutic benefit. ProKera Plus® has several advantages over sutured AMT including ease of administration in a clinic setting and reduced overall procedural cost.

The role of ProKera® in the treatment algorithm of corneal ulcers has yet to be fully clarified. There are currently no prospective case studies comparing the use of ProKera® to standard of care conventional treatments in corneal ulcers. The utility of this device would provide valuable information in the treatment of bacterial corneal ulcers.

The objectives are:

1. To determine if ProKera Plus® can lead to better visual recovery when used with bacterial corneal ulcers compared to conventional treatment
2. To determine if ProKera Plus® can actively modify corneal wound healing during the course of managing bacterial corneal ulcers and decrease the overall time to re-epithelialization
3. To determine if ProKera Plus® can decrease pain associated with bacterial corneal ulcers compared to conventional treatment
4. To determine if ProKera Plus® can decrease the amount of corneal opacity and corneal thinning associated with bacterial corneal ulcers compared to conventional treatment
5. To determine if ProKera Plus® can decrease the need for further interventions or surgeries related to complications from bacterial corneal ulcers

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria

  * Subjects 18 years of age or older, all sexes and races
  * Willing to sign a written informed consent to participate
  * Corneal ulcer criteria: at least 3mm in diameter, opacification located within 3mm of visual axis, infiltrate occupying at least 50% of the corneal thickness, moderate AC cell reaction, clinical picture consistent with bacterial infection later confirmed by culture and gram stain.

Exclusion Criteria:

* History of Immunodeficiency
* History of connective tissue disorders or severe atopic disease
* History of chemical eye injuries
* History of known limbal stem cell deficiency
* History of neurotrophic keratopathy
* History of recent eye surgery, or glaucoma surgery with bleb or drainage tube
* Risk factors and clinical appearance consistent with fungal keratitis

Primary outcomes:
measure: Visual Acuity - Visit 1
timeFrame: 5-day Follow-Up, plus or minus 3 days
measure: Visual Recovery - Visit 2
timeFrame: 16-day follow-up plus or minus 5 days
measure: Visual Recovery - Visit 3
timeFrame: 30-day follow-up plus or minus 7 days
measure: Visual Recovery - Visit 4
timeFrame: 90 day follow-up plus or minus 10 days
measure: Visual Recovery - Visit 5
timeFrame: 180-day follow-up plus or minus 14 days
Secondary outcomes:
measure: Corneal Re-epithelialization - Visit 1
timeFrame: 5-day follow-up plus or minus 3 days
measure: Corneal Re-epithelialization - Visit 2
timeFrame: 16-day follow-up plus or minus 5 days
measure: Corneal Re-epithelialization - Visit 3
timeFrame: 30-day follow-up plus or minus 7 days
measure: Corneal Re-epithelialization - Visit 4
timeFrame: 90-day follow-up plus or minus 10 days
measure: Corneal Opacity Size - Visit 1
timeFrame: 5-day follow-up plus or minus 3 days
measure: Corneal Opacity Size - Visit 3
timeFrame: 30-day follow-up plus or minus 7 days
measure: Corneal Opacity Thinning-Visit 1
timeFrame: 5-day follow-up plus or minus 3 days
measure: Corneal Opacity Thinning-Visit 3
timeFrame: 30-day follow-up plus or minus 7 days
measure: Eye Pain- Visit 1
timeFrame: 5-day follow-up plus or minus 3 days
measure: Eye Pain- Visit 2
timeFrame: 16-day follow-up plus or minus 5 days
measure: Eye Pain- Visit 3
timeFrame: 30-day follow-up plus or minus 7 days
measure: Eye Pain- Visit 4
timeFrame: 90-day follow-up plus or minus 10 days
measure: Eye Pain- Visit 5
timeFrame: 180-day follow-up plus or minus 14 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University Of Arkansas For Medical Sciences, Jones Eye Institute
name: David Warrner, MD
role: PRINCIPAL_INVESTIGATOR
References: