Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK
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|ClinicalTrials.gov Identifier: NCT02227147|
Recruitment Status : Completed
First Posted : August 27, 2014
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Formulation containing antioxidant
Other Name: Vehicle
- Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reviewer [ Time Frame: Week 8 ]Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures.
- Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by the Investigator [ Time Frame: Week 8 ]Percentage of patients experiencing complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as measured by the investigator.
- Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator. [ Time Frame: At weeks 4 and 6 ]Percentage of patients experiencing complete healing of the PED or corneal ulcer at 4, and 6 weeks as measured by the central reading center evaluating the clinical pictures and investigator.
- Percentage of Patients With Complete Corneal Clearing [ Time Frame: at weeks 4, 6, and 8 ]Percentage of patients with complete corneal clearing at weeks 4, 6, and 8 defined as grade 0 on the modified Oxford scale. Grade 0 indicates the absence of conjunctival staining; grade V indicates severe conjunctival staining.
- Mean Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA) [ Time Frame: Baseline, Week 8 ]
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8.
Best Corrected Distance Visual Acuity consists of letters read at 4m only.
- Percentage of Patients That Achieve a 15 Letter Gain in BCDVA [ Time Frame: Weeks 4, week 6 and week 8 ]Percentage of patients that achieve a 15 letter gain in Best Corrected Distance Visual Acuity (BCDVA) at 4 weeks, 6 weeks, 8 weeks
- Improvement in Corneal Sensitivity [ Time Frame: At 4, 6 and 8 weeks after start of the treatment ]
Improvement in corneal sensitivity was measured by the Cochet-Bonnet aesthesiometer at 4, 6 and 8 weeks.
Corneal sensitivity is measured continuously in each patient in cm:
- Area of the Persistent Epithelial Defect (PED) or corneal ulcer
- All quadrants, but outside the PED or corneal ulcer area: Superior nasal, inferior nasal, superior temporal, inferior temporal.
Improvement is defined as an increase of at least 0.5 cm in the location of concern.
- Patients Experiencing Deterioration [ Time Frame: from baseline to Week 8. ]Number of patients experiencing deterioration (increase in lesion size ≥ 1mm and/or decrease in BCDVA by >5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and/or progression in lesion depth to corneal melting or perforation and/or onset of infection) in stage 2 or 3 NK from baseline to Week 8.
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 ClinicalTrials.gov identifier (NCT number): NCT02227147
|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|
|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|
|Study Director:||Flavio Mantelli, MD, PhD||Dompé farmaceutici S.p.A., Milan|