Neurotrophic KeratitisPhase 4IMAGONCT06411145

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

A Phase 4 study testing OXERVATE® 0.002% in people with Neurotrophic Keratitis and Neurotrophic Keratopathy, run by Dompé Farmaceutici S.p.A.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurotrophic Keratitis, Neurotrophic Keratopathy, Corneal Ulcer
What is being tested?: OXERVATE® 0.002%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 26 Apr 2024to 12 Nov 2024
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient must be ≥18 years of age at time of screening.
Patient must be stage 3 NK in the study eye defined by the Mackie Criteria at baseline (Appendix 4).
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.
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.
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.
Patients must have the ability and willingness to comply with study procedures and study product dosing as described in the protocol.
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.

Who cannot join

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.
Evidence of a necrotizing herpetic ulcer in either eye at the time of screening or baseline.
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.
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.
Patients who have excessive, pre-existing corneal opacification.
Any of the following within 90 days of study enrollment:

Show all 19Show fewer

Treatment with Botox (botulinum toxin) injections in the study eye to induce pharmacologic blepharoptosis
Treatment with intravenous chemotherapy for oncologic pathology
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.
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.
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.
Previously been treated with OXERVATE®
Ocular surgeries (including but not limited to LASIK, PRK, tube shunt/trabeculectomy, cataract surgery) within the last 6 months.
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
Female patients who are pregnant or lactating at study screening or baseline, or those who are planning pregnancy during the period of study.
Premenopausal females not using a medically acceptable form of birth control (abstinence, pharmaceutical contraception, intrauterine device, surgically sterilized) during the treatment period.
History of drug addiction or alcohol abuse documented within the past 2 years.
Patients who are active smokers shall be excluded.
Actively participating in a clinical trial at time of enrollment.

About this study

Official title: A Prospective, Multicenter Trial to Evaluate Efficacy and Safety of Cenegermin-bkbj (20 mcg/mL) Ophthalmic Solution on Corneal Thickness Via Anterior Segment Optical Coherence Tomography (AS-OCT) in Stage 3 Neurotrophic Keratitis

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:

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

Conditions: Neurotrophic Keratitis, Neurotrophic Keratopathy, Corneal Ulcer
Being tested: OXERVATE® 0.002%
Keywords: stage 3 keratitis, cenegermin-bkbj, OXERVATE®, rhNGF
Medical subject headings: Corneal Ulcer, Keratitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OXERVATE® 0.002%Drug
Also called cenegermin-bkbj
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.

Study groups in NCT06411145
Study group	Role	What they receive
Cenegermin-bkbj	Experimental	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. Receives: Drug: OXERVATE® 0.002%

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: weeks 4, 8, and 16.

Secondary outcomes (4)

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
Measured: weeks 4, 8, and 16
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
Measured: weeks 4, 8, and 16
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
Measured: weeks 4, 8, and 16
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.
Measured: Throughout the study until Day 112 +/- 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 202412 Nov 2024

First posted13 May 2024
Study start26 Apr 2024
Primary completion12 Nov 2024
Study completion12 Nov 2024

Why it stopped: The study was withdrawn prior to enrolling subjects due to realignment of strategic priorities.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurotrophic 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Cenegermin-bkbj (20 mcg/mL) ophthalmic solution contained in a multiple-dose vial. The topical drops are administered 6 times/day for a 6-week course.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06411145
Sponsor's protocol ID: NGF0223
Acronym: IMAGO
Status last verified: Nov 2024
First submitted: 8 May 2024
Last updated: 2 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 2
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Neurotrophic Keratitis
RecruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Ocular Surface Disease, Neurotrophic Keratopathy Stage 1

All Neurotrophic Keratitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Trial to Evaluate Efficacy and Safety of Cenegermin-bkbj (20 mcg/mL) Ophthalmic Solution on Corneal Thickness Via Anterior Segment Optical Coherence Tomography (AS-OCT) in Stage 3 Neurotrophic Keratitis
ClinicalTrials.gov ID: NCT06411145
Acronym / sponsor ID: IMAGO / NGF0223
Conditions: Neurotrophic Keratitis, Neurotrophic Keratopathy, Corneal Ulcer
Keywords: stage 3 keratitis, cenegermin-bkbj, OXERVATE®, rhNGF
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The study was withdrawn prior to enrolling subjects due to realignment of strategic priorities.
Enrolment: 0 participants (actual)
Lead sponsor: Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
Study start: 26 Apr 2024 (actual)
Primary completion: 12 Nov 2024 (actual)
Study completion: 12 Nov 2024 (actual)
First posted: 13 May 2024 (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.

Primary Objective:

Secondary Objectives:

Detailed description

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.

Visits list:

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Cenegermin-bkbj (20 mcg/mL) ophthalmic solution contained in a multiple-dose vial. The topical drops are administered 6 times/day for a 6-week course.

Arm	Type	Receives
Cenegermin-bkbj	Experimental	Drug: OXERVATE® 0.002%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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patient must be ≥18 years of age at time of screening.
Patient must be stage 3 NK in the study eye defined by the Mackie Criteria at baseline (Appendix 4).
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.
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.
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.

Key exclusion criteria (19 listed)

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.
Evidence of a necrotizing herpetic ulcer in either eye at the time of screening or baseline.
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.
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.
Patients who have excessive, pre-existing corneal opacification.

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
OXERVATE® 0.002%Also: cenegermin-bkbjCenegermin-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.	Drug	Cenegermin-bkbj

Primary outcome

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

4 secondary outcomes

Change in corneal stromal thickness via AS-OCT from baseline to weeks 4, 8, and 16.
Time frame: weeks 4, 8, and 16
Change in stromal reflectivity via AS-OCT from baseline to weeks 4, 8, and 16
Time frame: weeks 4, 8, and 16
Change in corneal sensitivity within lesion area via Cochet-Bonnet from baseline to weeks 4, 8, and 16.
Time frame: weeks 4, 8, and 16
Frequency and severity of TEAE throughout the study until the FU week 16 assessment (Day 112 +/- 3)
Time frame: Throughout the study until Day 112 +/- 3

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 2 Dec 2024.
Individual participant dataSharing planned: No

Related trials for Neurotrophic Keratitis

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 2
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Neurotrophic Keratitis
RecruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency
Ocular Surface Disease, Neurotrophic Keratopathy Stage 1

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.

Brad Kligman, MD principal investigator

SightMD, New York, New York

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OXERVATE® 0.002% in people with Neurotrophic Keratitis and Neurotrophic Keratopathy, run by Dompé Farmaceutici S.p.A.

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 7 inclusion and 19 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in overall corneal thickness via AS-OCT from baseline to weeks 4, 8, and 16. (time frame: weeks 4, 8, and 16.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06411145.

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 2 Dec 2024.