Trial · NCT02110225

A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)

NCT02110225, Phase 1, Phase 2, Completed, Dompé Farmaceutici S.p.A; results first posted 2019-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP). Trials, record NCT02110225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02110225

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose Ranging Study to Evaluate the Safety and Potential Efficacy of rhNGF in Patients With Retinitis Pigmentosa (RP)
NCT number: NCT02110225
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 50 participants, actual
Lead sponsor: Dompé Farmaceutici S.p.A
Conditions: Retinitis Pigmentosa
Interventions: rhNGF 60 µg/ml eye drops solution, rhNGF 180 µg/ml eye drops solution, Placebo
First posted: 2014-04-10
Last updated: 2024-04-18
Other registries' IDs: eudract:2013-003029-26
Results first posted: 2019-07-11
Limitations and caveats: LImitations and caveats non specified

Source ClinicalTrials.gov

Registered outcomes16

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

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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Serious and Non-Serious Adverse Events	up to 48 weeks	Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Ocular Tolerability - VAS	Weeks 1, 2, 6, 12, 24	Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	units on a scale	MEAN
PRIMARY	Change in Best Corrected Distance Visual Acuity (BCDVA) (ETDRS Chart)	Weeks 1, 2, 6, 12, 24, 36, 48	Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	Letters read correctly	MEAN
PRIMARY	Change in Intraocular Pressure (IOP)	Weeks 2,12 and 24	Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	mmHg	MEAN
PRIMARY	Number of Participants With Normal or Abnormal Findings by Slit Lamp Examination	Day 0; Weeks 1, 2, 6, 12, 24, 36 and 48	s	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	External Ocular Examination	Day 0, Weeks 1, 2, 6, 12, 24	Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Ocular Tolerability - Dilated Fundus Ophthalmoscopy	Day 0, Weeks 12, 24 and 48	Safety population: all patients who received at least one dose of study medication.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Presence of Anti-NGF Antibodies	At Day 0 and at week 24	Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Contrast Sensitivity	Weeks 12, 24, 36 and 48	Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.	score	MEAN
SECONDARY	Change From Baseline in Humphrey Visual Field 24-2	Weeks 12, 24, 36 and 48	Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.	dB	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group747

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Serious and Non-Serious Adverse Events	rhNGF 60µg/ml		11		Participants
Number of Participants With Serious and Non-Serious Adverse Events	rhNGF 180 µg/ml		13		Participants
Number of Participants With Serious and Non-Serious Adverse Events	Vehicle		3		Participants
Change in Ocular Tolerability - VAS	rhNGF 60µg/ml	Foreign body sensation - Left eye, Wk 1 vs Day 0	5.45	Standard Deviation 15.23	units on a scale
Change in Ocular Tolerability - VAS	rhNGF 180 µg/ml	Foreign body sensation - Left eye, Wk 1 vs Day 0	4.80	Standard Deviation 21.31	units on a scale
Change in Ocular Tolerability - VAS	Vehicle	Foreign body sensation - Left eye, Wk 1 vs Day 0	3.50	Standard Deviation 11.07	units on a scale
Change in Ocular Tolerability - VAS	rhNGF 60µg/ml	Foreign body sensation - Right eye, Wk 1 vs Day 0	5.75	Standard Deviation 15.41	units on a scale
Change in Ocular Tolerability - VAS	rhNGF 180 µg/ml	Foreign body sensation - Right eye, Wk 1 vs Day 0	10.95	Standard Deviation 24.44	units on a scale
Change in Ocular Tolerability - VAS	Vehicle	Foreign body sensation - Right eye, Wk 1 vs Day 0	4.30	Standard Deviation 14.31	units on a scale
Change in Ocular Tolerability - VAS	rhNGF 60µg/ml	Foreign body sensation - Left eye, Wk 2 vs Day 0	3.50	Standard Deviation 9.05	units on a scale

1 to 10 of 747Source ClinicalTrials.gov

See all 747 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	rhNGF 60µg/ml	20
Overall Study	STARTED	rhNGF 180 µg/ml	20
Overall Study	STARTED	Vehicle	10
Overall Study	COMPLETED	rhNGF 60µg/ml	20
Overall Study	COMPLETED	rhNGF 180 µg/ml	19
Overall Study	COMPLETED	Vehicle	10
Overall Study	NOT COMPLETED	rhNGF 60µg/ml	0
Overall Study	NOT COMPLETED	rhNGF 180 µg/ml	1
Overall Study	NOT COMPLETED	Vehicle	0

Source ClinicalTrials.gov

Adverse events81

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Extrasystoles	Cardiac disorders	rhNGF 60µg/ml	0	20	0
other	Extrasystoles	Cardiac disorders	rhNGF 180 µg/ml	0	20	0
other	Extrasystoles	Cardiac disorders	Vehicle	1	10	1
other	Abnormal sensation in eye	Eye disorders	rhNGF 60µg/ml	1	20	1
other	Abnormal sensation in eye	Eye disorders	rhNGF 180 µg/ml	0	20	0
other	Abnormal sensation in eye	Eye disorders	Vehicle	0	10	0
other	Blepharitis	Eye disorders	rhNGF 60µg/ml	3	20	3
other	Blepharitis	Eye disorders	rhNGF 180 µg/ml	0	20	0
other	Blepharitis	Eye disorders	Vehicle	0	10	0
other	Conjunctival hyperemia	Eye disorders	rhNGF 60µg/ml	1	20	1

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	rhNGF 60µg/ml	0	20
Total, all-cause mortality	rhNGF 180 µg/ml	0	20
Total, all-cause mortality	Vehicle	0	10
Total, other adverse events	rhNGF 60µg/ml	11	20
Total, other adverse events	rhNGF 180 µg/ml	13	20
Total, other adverse events	Vehicle	3	10
Total, serious adverse events	rhNGF 60µg/ml	1	20
Total, serious adverse events	rhNGF 180 µg/ml	0	20
Total, serious adverse events	Vehicle	0	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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