Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Number of Participants With Serious and Non-Serious Adverse Events	up to 48 weeks	Twenty-seven patients of the Safety population experienced at least one treatment-emergent adverse event, 11 patients in the rhNGF 60 μg/ml arm, 13 patients in the rhNGF 180 μg/ml arm and 3 patients in the vehicle arm.
Primary	Change in Ocular Tolerability - VAS	Weeks 1, 2, 6, 12, 24	A global ocular discomfort score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. For ocular tolerability analysis, mixed models for repeated measures were applied using various ocular tolerability parameters as response variable, treatment, visit and treatment by visit interaction as fixed effects, and baseline value as covariate.
Primary	Change in Best Corrected Distance Visual Acuity (BCDVA) (ETDRS Chart)	Weeks 1, 2, 6, 12, 24, 36, 48	Best-Corrected Distance Visual Acuity (BCDVA) was assessed for each eye at each visit using an ETDRS visual acuity chart at 4 meters.
Primary	Change in Intraocular Pressure (IOP)	Weeks 2,12 and 24	Intraocular Pressure was measured using either Goldmann applanation tonometry or a handheld applanation tonometer (e.g. Tonopen) after the instillation of a topical anesthetic.IOP was assessed for each eye at day 0 and at week 2, 12 and 24
Primary	Number of Participants With Normal or Abnormal Findings by Slit Lamp Examination	Day 0; Weeks 1, 2, 6, 12, 24, 36 and 48	Slit Lamp Examination (SLE) (Biomicroscopy) was performed before the instillation of any dilating or anesthetic eye drops or fluorescein agents. SLE was executed to assess eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber.
Primary	External Ocular Examination	Day 0, Weeks 1, 2, 6, 12, 24	External ocular examinations were done to assess, for each eye and at each visit, the motility of extraocular muscles, appearance and function of the eyelids.
Primary	Change in Ocular Tolerability - Dilated Fundus Ophthalmoscopy	Day 0, Weeks 12, 24 and 48	Dilated fundus ophthalmoscopy was assessed for each eye evaluating the retina, macula, choroid and optic nerve head.
Primary	Presence of Anti-NGF Antibodies	At Day 0 and at week 24	Anti-NGF antibodies tests were performed at screening and at the end of treatment
Secondary	Change From Baseline in Contrast Sensitivity	Weeks 12, 24, 36 and 48	Contrast sensitivity was assessed using a Mars chart and is expressed as a log contrast sensitivity (log CS) score given by the log CS value at the lowest contrast numeral just prior to two incorrectly identified numerals, minus a scoring correction. The higher is the number of characters properly read by the patient, the higher is the contrast sensitivity.
Secondary	Change From Baseline in Humphrey Visual Field 24-2	Weeks 12, 24, 36 and 48	The Humphrey Visual Field (HVF) analyzer is a tool for measuring the human visual field by providing information regarding the location of any disease processes or lesion(s) throughout the visual pathway. In particular, Humphrey Visual Field 24-2 was used to assess static perimetry by measuring 24 degrees temporally and 30 degrees nasally and tests 54 points. The Analyser projects a series of white light stimuli of varying intensities (brightness), throughout a uniformly illuminated bowl. The higher is the number of stimuli perceived by the patient, the better is the retina's ability to detect a stimulus at specific points within the visual field.
Secondary	Change in Goldmann Visual Field	Weeks 12, 24, 36 and 48	The Goldmann field exam was performed to assess kinetic perimetry on all enrolled patients.
Secondary	Fundus Imaging	Day 0, Weeks 24 and 48	A recordable fundus image (photo or other electronic format) showing the central 30 degrees was captured through a dilated pupil to document the appearance of the posterior pole.
Secondary	Ocular Coherence Tomography (OCT)	Day 0, Weeks 12, 24, 36 and 48	Ocular coherence tomography was performed to evaluate the cross-sectional anatomy of the macula and to document areas of retinal atrophy.
Secondary	Microperimetry	Day 0, Weeks 12, 24, 36 and 48	MP1 microperimetry was analyzed to provide a more accurate measurement of retinal sensitivity in the central visual field, even in patients with unstable or extrafoveal fixation.
Secondary	Binocular Estermann Visual Field	Day 0, Weeks 12, 24, 36 and 48	Binocular visual field with Estermann grid testing a stimulus array of 120 points spread over an area extending approximately ±75° horizontally, 35° superiorly and 55° inferiorly while the patient looked steadily at the fixation target.
Secondary	Electrorethinogram (ERG)	Day 0, Weeks 12, 24, 36 and 48	A full field and 30 Hz flicker ERG was performed according to international standards. Patients were treated with anesthetic and dilating drops prior to the ERG procedure.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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