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WithdrawnNCT06411145IMAGOUpdated Dec 2, 2024

Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis

A Phase 4 interventional study of OXERVATE® 0.002% in Neurotrophic Keratitis, Neurotrophic Keratopathy and Corneal Ulcer, sponsored by Dompé Farmaceutici S.p.A. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Dompé Farmaceutici S.p.A · Phase 4, Interventional, and Treatment

Why this study was withdrawn
The study was withdrawn prior to enrolling subjects due to realignment of strategic priorities.
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Primary Objective:

To assess the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on overall corneal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.

Secondary Objectives:

To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.

To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal reflectivity via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.

To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal sensitivity via Cochet-Bonnet aesthesiometer in the center of the lesion with respect to change from baseline at weeks 4, 8, and 16.

Read the detailed description

This clinical study is a prospective, open-label, interventional, multicenter study of 8 weeks of treatment with 8 weeks of follow-up after treatment to evaluate the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal thickness and stromal clarity via AS-OCT in patients with stage 3 neurotrophic keratitis.

The study will be a total of 16 weeks in duration: an optional screening period of up to 2 weeks, followed by an 8-week treatment period and an 8-week follow-up period. At Visit 1.2 (Baseline and Study Product Dispense, Day -1), patients meeting the entry criteria for this study will be assigned to treatment with cenegermin-bkbj (20 mcg/mL) ophthalmic solution (which will be known as Study Product) beginning the morning following that visit, or Day 0.

After completion of the Treatment Period, all patients who do not meet deterioration or no improvement criteria will continue to be followed for an additional 8-week Follow-Up Period.

At any time during the study, patients may be seen for additional unscheduled visits as deemed necessary by the Investigator.

For patients who are prematurely discontinued from the study at any point, an exit examination should be completed which represents the next data collection visit in the study timeline. Once exited, the Investigator should direct patients for further treatment as appropriate. Patients in this study who are prematurely discontinued before completion of 8 weeks of treatment with cenegermin-bkbj (20 mcg/mL) ophthalmic solution will continue to be followed throughout the remainder of the study period, if able.

To minimize risk of bias, all images will be assessed at an independent central reading center (CRC). The study site will acquire the images and perform a quality check; however, no analysis is required to be conducted by the Investigator on site.

Visits list:

  1. Visit 1.1- Screening Visit (Day -14 to -1)
  2. Visit 1.2- Baseline Visit and Study Product Dispensation (Day -1)
  3. Treatment Period (Weeks 1-8)
  4. Visit 2- Study Product Dispensation (Day 14 ± 3 days)
  5. Visit 3- Mid-Treatment Week 4 Evaluation and Study Product Dispensation(Day 28 ± 3 days)
  6. Visit 4- Study Product Dispensation Visit (Day 42 ± 3 days)
  7. Visit 5- End-of-Treatment Week 8 Evaluation (Day 56 ± 3 days)
  8. Follow-Up Period (Weeks 9-16)
  9. Visit 6- Final Follow-Up Week 16 Evaluation (Day 112 ± 3 days)
02

Conditions studied

  • Neurotrophic Keratitis
  • Neurotrophic Keratopathy
  • Corneal Ulcer

Keywords

  • stage 3 keratitis
  • cenegermin-bkbj
  • OXERVATE®
  • rhNGF
03

In context

Corneal Ulcer

60 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.

Browse Corneal Ulcer studies →

Lead sponsor

Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient must be ≥18 years of age at time of screening.
  2. Patient must be stage 3 NK in the study eye defined by the Mackie Criteria at baseline (Appendix 4).
  3. Evidence of decreased corneal sensitivity in the study eye as measured by Cochet-Bonnet esthesiometry (≤4 cm in the center of the neurotrophic lesion) at baseline.
  4. Patients who have only one functional eye can be included if they meet all the criteria above and per the Investigator's discretion are proper candidates to designate the one functional eye as the study eye.
  5. Self-retaining amniotic membrane or any other amniotic topical product may be used prior to baseline visit (Visit 2) but should be removed or fully dissolved by the baseline measurements.
  6. Patients must have the ability and willingness to comply with study procedures and study product dosing as described in the protocol.
  7. Only patients who satisfy all informed consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign, and date the Institutional Review Board (IRB)-approved informed consent document before any study-related procedures are performed.

Exclusion criteria

Exclusion Criteria:

  1. In the opinion of the Investigator, evidence or confirmed culture of an active ocular infection (bacterial, fungal, protozoal) in either eye at the time of screening or baseline.
  2. Evidence of a necrotizing herpetic ulcer in either eye at the time of screening or baseline.
  3. Active or severe corneal/ocular inflammation that requires continuous medical therapy throughout the duration of the treatment, including eyelid-based disorders such as severe MGD or blepharitis.
  4. Patients with posterior one-third corneal involvement or if posterior one-third of cornea becomes involved during the time between screening and baseline measurements, or at the Investigator's discretion is close to perforation.
  5. Patients who have excessive, pre-existing corneal opacification.
  6. Any of the following within 90 days of study enrollment:

    1. Treatment with Botox (botulinum toxin) injections in the study eye to induce pharmacologic blepharoptosis
    2. Treatment with intravenous chemotherapy for oncologic pathology
  7. Patients who have punctal occlusion planned within the study period. Patients who have undergone punctal occlusion prior to entry into the study are eligible for enrollment provided that the punctal occlusion is maintained during the study period. If a punctal plug falls out of the study eye during the study, it must be reinserted within 7 days of discovery via examination by the Investigator.
  8. Anticipated need to use therapeutic contact lenses, contact lens wear for refractive correction, or scleral contact lenses during the treatment period in the study eye.
  9. Patients with eyelid or neuromuscular abnormality that may alter eyelid function or closure, thereby increasing exposure; this includes but is not limited to blepharospasm, cranial nerve palsy or paresis, entropion, ectropion, or floppy eyelid syndrome.
  10. Previously been treated with OXERVATE®
  11. Ocular surgeries (including but not limited to LASIK, PRK, tube shunt/trabeculectomy, cataract surgery) within the last 6 months.
  12. History of corneal stromal surgery, including anterior lamellar keratoplasty (ALK), deep anterior lamellar keratoplasty (DALK), and penetrating keratoplasty (PKP) within 12 months of screening visit
  13. Female patients who are pregnant or lactating at study screening or baseline, or those who are planning pregnancy during the period of study.
  14. Premenopausal females not using a medically acceptable form of birth control (abstinence, pharmaceutical contraception, intrauterine device, surgically sterilized) during the treatment period.
  15. History of drug addiction or alcohol abuse documented within the past 2 years.
  16. Patients who are active smokers shall be excluded.
  17. Actively participating in a clinical trial at time of enrollment.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Cenegermin-bkbj

    cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal thickness administered as topical drops via anterior segment optical coherence tomography (AS-OCT), where cenergermin-bkbj stands for Topical Recombinant Human Nerve Growth Factor (rhNGF). Cenegermin-bkbj, the active ingredient of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution, is structurally identical to the human nerve growth factor (NGF) protein made in ocular tissues.

    Drug: OXERVATE® 0.002%

Interventions

  • Cenegermin-bkbj (20 mcg/mL) is an ophthalmic solution contained in a multiple-dose vial. The topical drops are administered 6 times/day for a 8-week course.

    Also known as: cenegermin-bkbj

06

What researchers measure

Primary outcomes

  1. Change in overall corneal thickness via AS-OCT from baseline to weeks 4, 8, and 16.

    The changes from baseline in corneal thickness via AS-OCT from baseline to weeks 4, 8, and 16 will be analyzed by means of an adjusted longitudinal regression model

    Time frame: weeks 4, 8, and 16.

Secondary outcomes

  1. Change in corneal stromal thickness via AS-OCT from baseline to weeks 4, 8, and 16.

    the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal thickness via AS-OCT will be assessed in patients with stage 3 neurotrophic keratitis

    Time frame: weeks 4, 8, and 16

  2. Change in stromal reflectivity via AS-OCT from baseline to weeks 4, 8, and 16

    corneal stromal reflectivity via AS-OCT in patients with stage 3 neurotrophic keratitis will be assessed

    Time frame: weeks 4, 8, and 16

  3. Change in corneal sensitivity within lesion area via Cochet-Bonnet from baseline to weeks 4, 8, and 16.

    Change in corneal sensitivity within lesion area via Cochet-Bonnet aesthesiometer will be assessed

    Time frame: weeks 4, 8, and 16

  4. Frequency and severity of TEAE throughout the study until the FU week 16 assessment (Day 112 +/- 3)

    AEs will be coded by preferred term and system organ class by using the latest version of the Medical Dictionary for Regulatory Activities AEs will be summarized overall, by severity, and by relationship to study product. Serious AEs and AEs leading to discontinuation of study product will also be summarized.

    Time frame: Throughout the study until Day 112 +/- 3

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2024 to primary completion in Nov 2024, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2024
First posted
May 13, 2024
StartActual
Apr 26, 2024
Primary completionActual
Nov 12, 2024
CompletionActual
Nov 12, 2024
Last update
Dec 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06411145
Responsible party
Sponsor
First posted
May 13, 2024
Start date
Apr 26, 2024
Primary completion
Nov 12, 2024
Completion
Nov 12, 2024
Last update
Dec 2, 2024

Study contacts

Brad Kligman, MD
principal investigator · SightMD, New York, New York

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cenegermin

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