Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma (NGF-Glaucoma)
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|ClinicalTrials.gov Identifier: NCT02855450|
Recruitment Status : Completed
First Posted : August 4, 2016
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control.
The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: rhNGF Drug: Vehicle||Phase 1|
This is an 8 Week phase Ib, monocentric, randomized, double-masked, vehicle controlled, parallel groups, study with a 24 Week follow-up period to evaluate the safety and potential efficacy of a 180 μg/ml recombinant human nerve growth factor (rhNGF) eye drops solution versus vehicle in 60 study participants with chronic primary open angle glaucoma.
Participants may qualify with either progressive optic neuropathy despite maximal current therapy (i.e. IOP reduction), or with stabilized IOP but diminished vision (central or peripheral).
Participants with a qualifying eye will be randomized 2:1 to topical recombinant human nerve growth factor (rhNGF) therapy or vehicle placebo control. Examinations for safety and efficacy will occur one week following initiation of therapy, and at 4, 8, 12 and 32 weeks.
All participants in either arm will be followed clinically at 4 weeks after cessation of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||An 8 Week Phase Ib, Monocentric, Randomized, Double-masked, Parallel Groups, Study With a 24 Week Follow-up to Evaluate Safety and Potential Efficacy of a 180 μg/ml rhNGF Eye Drops Solution Vs Vehicle in Patients With Glaucoma|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
rhNGF (Recombinant Human Nerve Growth Factor) 180 μg/ml eye drops solution
Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment.
Other Name: cenegermin
Placebo Comparator: Vehicle
Ophthalmic Placebo solution
Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment.
Other Name: placebo
- Incidence of Events as of Primary Safety Outcomes [ Time Frame: At day 56/end of treatment ]
Unexpected Severe Progression Of Optic Neuropathy (USPON) is a composed parameter which required at least 28 single evaluations; it occurred if the subject answered Yes to any of the following 4 questions on unexpected severe progression:
- Best Corrected Distance Visual Acuity (BCDVA): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose
- Humphrey Visual Field (HVF): 'Yes' for at least one treated eye in at least one assessment during treatment or follow-up period
- Electroretinography (ERG): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose
- Optical Coherence tomography (OCT): 'Yes' for at least one treated eye at any Follow-Up Visit after first study drug dose
Intolerance and allergy to the drug was identified based on preferred term of treatment-emergent adverse events.
URAEs are unexpected related AE affecting ocular function. Local/systemic toxicities were identified via the AE form
- Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score [ Time Frame: Change from baseline to days 7, 28 and 56 (Treatment period), and Day 84 (Follow up) ]
A ocular tolerability score was determined using a 100 mm VAS on which 0 meant No symptoms and 100 meant the Worst possible discomfort. The patients subjectively evaluated their ocular symptoms (foreign body sensation, burning or stinging, itching, pain, sticky feeling, blurred vision and photophobia) using the VAS giving the value they were feeling from none to an extreme value.
The ocular symptoms were evaluated by the patients through the scale. Only "overall" values for primary eye and secondary eye are reported here under.
An eye was considered as Primary eye, if
- the eye was treated and
- the investigator considered this eye as qualifying eye.
- If both eyes were considered as qualifying eye, the right eye was chosen.
The other eye was then considered as Secondary eye, if the eye was treated.
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): NCT02855450
|United States, California|
|Byers Eye Institute at Stanford University|
|Palo Alto, California, United States, 94303|
|Principal Investigator:||Jeffrey L Goldberg, MD, PhD||, MD, PhD|