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Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02227147
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief Summary:

The primary objective of this study is to evaluate the efficacy of 20 µg/ml 6 times a day of rhNGF eye drops solution (formulation containing anti-oxidant) compared to vehicle (formulation containing anti-oxidant) given 6 times a day. The evaluation of efficacy is intended as:

  • complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis (NK) as measured by the central reading center using corneal fluorescein staining,
  • assessing the duration of complete healing,
  • improvement in visual acuity and improvement in corneal sensitivity.

Condition or disease Intervention/treatment Phase
Neurotrophic Keratitis Drug: rhNGF 20µg/ml Other: Placebo Phase 2

Detailed Description:

An 8-week phase II, multicenter, randomized, double-masked, vehicle-controlled, parallel group study with a 24 or 32 week follow-up period to evaluate the efficacy of a formulation containing anti-oxidant of recombinant human nerve growth factor (rhNGF) in 20 μg/ml, eye drops solution versus vehicle containing anti-oxidant in patients with Stage 2 and 3 Neurotrophic Keratitis. The primary objective was to evaluate the efficacy of 20 μg/ml 6 times a day of recombinant human nerve growth factor (rhNGF) containing anti-oxidant, eye drops solution compared to vehicle (formulation containing anti-oxidant) given 6 times a day in inducing a complete healing of stage 2 (PED) and 3 (corneal ulcer) NK as measured by the central reading center, evaluating the clinical pictures of corneal fluorescein staining.

Secondary objectives were to assess the duration of complete healing, improvement in visual acuity and improvement in corneal sensitivity, and percentage of patients achieving complete corneal clearing defined as complete absence of staining on the modified Oxford Scale.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An 8-week Phase II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study With a 24 or 32 Week Follow-up to Evaluate the Efficacy of rhNGF 20 µg/ml vs Vehicle in Patients With Stage 2 and 3 Neurotrophic Keratitis
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Experimental: rhNGF 20 µg/ml
rhNGF 20 µg/ml eye drops solution, formulation containing anti-oxidant
Drug: rhNGF 20µg/ml
Other Name: cenegermin

Placebo Comparator: Placebo
Vehicle: formulation containing anti-oxidant
Other: Placebo
Formulation containing antioxidant
Other Name: Vehicle

Primary Outcome Measures :
  1. Complete healing of the PED or corneal ulcer [ Time Frame: Week 8 ]
    Percentage of patients achieving complete healing of the PED (Persistent Epithelial Defect) or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center evaluating clinical pictures.

Secondary Outcome Measures :
  1. Improvement in visual acuity [ Time Frame: Week 8 ]
    • Mean change in BCDVA from baseline to Week 8. Analysis of variance will be used to compare the mean change between treatment groups.
    • Percentage of patients that achieve a 15 letter gain in BCDVA at 4, 6 and 8 weeks. Treatment will be compared at each time point by means of Chi-square test.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 years of age or older.
  • Patients with stage 2 (persistent epithelial defect, PED) or stage 3 (corneal ulcer) neurotrophic keratitis.
  • PED or corneal ulceration of at least 2 weeks duration refractory to one or more conventional non-surgical treatments for neurotrophic keratitis.
  • Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
  • Best corrected distance visual acuity (BCDVA) score ≤ 75 ETDRS (Early Treatment Diabetic Retinopathy Study)letters, (≥ 0.2 LogMAR, ≤ 20/32 Snellen or ≤ 0.625 decimal fraction) in the affected eye(s).
  • No objective clinical evidence of improvement in the PED or corneal ulceration within the 2 weeks prior to study enrolment.
  • 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 Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the IRB (Institutional Review Board) for the current study.
  • Patients must have the ability and willingness to comply with study procedures.

Exclusion Criteria:

  • Any active ocular infection or active ocular inflammation not related to NK in the affected eye(s).
  • Any other ocular disease requiring topical ocular treatment during the course of the study treatment period. No topical treatments other than the study medications provided by the study sponsor and allowed by the study protocol can be administered in the affected eye(s) during the course of the study treatment periods.
  • Patients with severe vision loss with no potential for visual improvement in the opinion of the investigator as a result of the study treatment.
  • Schirmer test without anesthesia ≤3 mm/5 minutes.
  • Patients with severe blepharitis and/or severe meibomian gland disease.
  • History of any ocular surgery (including laser or refractive surgical procedures) within the three months before study enrolment. (An exception to the preceding statement will be allowed if the ocular surgery is considered to be the cause of the stage 2 or 3 NK). Ocular surgery will not be allowed during the study treatment period and elective ocular surgery procedures should not be planned during the duration of the follow-up period.
  • Prior surgical procedure(s) for the treatment of NK with the exception of amniotic membrane transplantation. Patients previously treated with amniotic membrane transplantation may only be enrolled two weeks after the membrane has disappeared within the area of the PED or corneal ulcer or at least six weeks after the date of the amniotic membrane transplantation procedure.
  • Patients previously treated with Botox injections used to induce pharmacologic blepharoptosis are eligible for enrolment only if the last injection was given at least 90 days prior to enrolment in the study.
  • Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the study treatment period in the eye(s) with NK.
  • Anticipated need for punctual occlusion during the study treatment period. Patients with punctual occlusion or punctual plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained during the study.
  • Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation.
  • Presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.
  • Any need for or anticipated change in the dose of systemic medications known to impair the function of the trigeminal nerve. These treatments are allowed during the study if initiated prior study enrolment provided they remain stable throughout the course of the study treatment periods.
  • Known hypersensitivity to one of the components of the study or procedural medications (e.g. fluorescein).
  • History of drug, medication or alcohol abuse or addiction.
  • Use of any investigational agent within 4 weeks of screening visit.
  • Participation in another clinical study at the same time as the present study.
  • Females of childbearing potential are excluded from participation in the study if they meet any one of the following conditions: are currently pregnant or, have a positive result on the urine pregnancy test at the Randomization Visit or, intend to become pregnant during the study treatment period or, are breast-feeding or are not willing to use highly effective birth control measures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02227147

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United States, California
Loma Linda University Ophthalmology
Loma Linda, California, United States, 92354
Jules Stein Eye Institute
Los Angeles, California, United States, 90095
Shiley Eye Center University of California
San Diego, California, United States, 92093
United States, Florida
Bascom Palmer Eye Institute University of Miami
Miami, Florida, United States, 33324
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States, 02114
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, United States, 02451
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Pennsylvania
Penn Eye Care Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
UPMC eye center, department of ophthalmology, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
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Study Director: Flavio Mantelli, MD, PhD Dompé farmaceutici S.p.A., Milan

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Responsible Party: Dompé Farmaceutici S.p.A Identifier: NCT02227147     History of Changes
Other Study ID Numbers: NGF0214
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Keywords provided by Dompé Farmaceutici S.p.A:
Neurotrophic Keratitis

Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs