18 completed, 2 recruiting, 2 withdrawn, 1 active not recruiting. 8 Phase 2, 6 Phase 1, 4 Phase 3, 3 Phase 4, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 8 |
| Phase 1 | 6 | Completed 5, Withdrawn 1 |
| Phase 3 | 4 | Completed 2, Recruiting 2 |
| Phase 4 | 3 | Active not recruiting 1, Completed 1, Withdrawn 1 |
| Not applicable | 1 | Not yet recruiting 1 |
Follow cenegermin: new trials by email Literature Review of cenegermin trials Research Report on cenegermin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Cenegermin, Vehicle - Non-Arteritic Anterior Ischemic Optic Neuropathy | Phase 3 | Recruiting | Dompé Farmaceutici S.p.A | 272 | 2026-07-01 | 2026-10-27 |
| An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED Cenegermin, Vehicle - Persistent Corneal Epithelial Defect | Phase 3 | Recruiting | Dompé Farmaceutici S.p.A | 150 | 2026-06-02 | 2026-10-07 |
| Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study Corneal Neurotization, Cenergermin - Neurotrophic Keratitis | Not applicable | Not yet recruiting | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 10 | 2025-08-01 | 2025-07-18 |
| Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis OXERVATE® 0.002% - Neurotrophic Keratitis, Neurotrophic Keratopathy | Phase 4 | Withdrawn | Dompé Farmaceutici S.p.A | 2024-04-26 | 2024-12-02 | |
| A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease. rhNGF 5 μg/mL, rhNGF 10 μg/mL, Vehicle (Placebo solution) - Dry Eye Disease | Phase 2 | Completed | Dompé Farmaceutici S.p.A | 317 | 2024-01-22 | 2026-02-13 |
| DEFENDO Long Term Follow-up Study in Stage 1 NK Patients Cenegemin in the DEFENDO Study - Neurotrophic Keratitis | Completed | Dompé Farmaceutici S.p.A | 24 | 2023-02-01 | 2025-11-28 | |
| DOMPE -MT Neurotrophic Keratitis Cenegermin Ophthalmic Solution [Oxervate] - Dry Eye, Neurotrophic Keratitis | Phase 4 | Active not recruiting | Toyos Clinic | 10 | 2023-01-21 | 2025-04-27 |
| NGF Treatment for Patients With Neuropathic Corneal Pain Cenegermin-Bkbj - Corneal Disease, Neuropathy | Phase 1 | Withdrawn | Tufts Medical Center | 2022-11-01 | 2023-01-26 | |
| Corneal Nerves After Treatment With Cenegermin Cenegermin Ophthalmic Solution [Oxervate] - Neurotrophic Keratitis | Completed | University of California, Los Angeles | 8 | 2022-05-23 | 2025-04-01 | |
| Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease Cenegermin, Vehicle - Dry Eye Disease | Phase 3 | Completed | Dompé Farmaceutici S.p.A | 85 | 2022-01-27 | 2025-11-26 |
| Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study) Oxervate, Vehicle - Dry Eye | Phase 3 | Completed | Dompé Farmaceutici S.p.A | 104 | 2022-01-19 | 2024-06-07 |
| Nerve Growth Factor for the Treatment of Cornea Disease Cenegermin-Bkbj - Neurotrophic Keratitis | Completed | Stanford University | 5 | 2020-10-14 | 2021-12-14 | |
| OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE] - Neurotrophic Ulcer, Neurotrophic Keratitis | Unknown | Sight Medical Doctors PLLC | 10 | 2020-10-01 | 2024-04-17 | |
| Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis cenegermin-bkbj - Neurotrophic Keratitis | Phase 4 | Completed | Dompé Farmaceutici S.p.A | 37 | 2020-09-09 | 2025-11-17 |
| A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye rhNGF 20 μg/ml, rhNGF 20 μg/ml + vehicle, Vehicle - Dry Eye Syndrome | Phase 2 | Completed | Dompé Farmaceutici S.p.A | 261 | 2019-06-10 | 2024-04-19 |
| Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers rhNGF 20μg/mL, Placebo - Healthy Volunteers | Phase 1 | Completed | Dompé Farmaceutici S.p.A | 30 | 2018-03-30 | 2023-12-26 |
| An 8-week Follow-up to Evaluate the Renewal of Corneal Nerves Structure and Function in Patients With Neurotrophic Keratopathy Treated With Recombinant Human Nerve Growth Factor (rhNGF) Eyedrops Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops - Neurotrophic Keratopathy | Completed | G. d'Annunzio University | 18 | 2018-03-01 | 2020-03-05 | |
| An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye NGF, Vehicle - Dry Eye | Phase 2 | Completed | Dompé Farmaceutici S.p.A | 150 | 2017-01-20 | 2019-02-08 |
| Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma rhNGF, Vehicle - Glaucoma | Phase 1 | Completed | Dompé Farmaceutici S.p.A | 60 | 2016-12-01 | 2020-11-25 |
| Nerve Growth Factor Eye Drops Treatment in Patients With Retinitis Pigmentosa and Cystoid Macular Edema rhNGF 180 µg/ml eye drops solution, vehicle eye drops - Retinitis Pigmentosa, Cystoid Macular Edema | Phase 2 | Completed | Ospedale San Raffaele | 45 | 2015-05-01 | 2017-09-06 |
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Dry Eye Syndromes (7) · Corneal Diseases (2) · Corneal Ulcer (2) · Keratitis (2) · Retinitis Pigmentosa (2) · Cone-Rod Dystrophies (1) · Conjunctivitis, Allergic (1) · Glaucoma (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Macular Edema (1) · Optic Nerve Diseases (1) · Optic Neuropathy, Ischemic (1)
Dompé Farmaceutici S.p.A (17) · G. d'Annunzio University (1) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (1) · Ospedale San Raffaele (1) · Sight Medical Doctors PLLC (1) · Stanford University (1) · Toyos Clinic (1) · Tufts Medical Center (1) · University of California, Los Angeles (1)
United States (17) · Italy (8) · United Kingdom (4) · France (2) · Germany (2) · Poland (2) · South Korea (2) · Spain (2) · Argentina (1) · Australia (1) · Austria (1) · Canada (1) · Czechia (1) · Hungary (1) · Japan (1)
Flavio Mantelli, MD, PhD (7) · Brad Kligman, MD (2) · Flavio Mantelli, MD (2) · Alex Camacho, MD, MSc (1) · Anastasiya Vinokurtseva, MD, Resident (1) · Ashley Brooks, MBChB (1) · Christopher N Ta, MD (1) · Cindy Hutnik, MD, PhD, Department Chief (1) · Francesco Sinigaglia, MD (1) · Giacomina Massaro Giordano, MD (1) · Jeffrey L Goldberg, MD, PhD (1) · Leonardo Mastropasqua, Professor (1) · Mauro P Ferrari, PharmD (1) · Monali Malvankar, PhD, Professor (1)
PMID 24327173, PMID 26448169, PMID 30944103, PMID 34780798, PMID 36353571, PMID 38175466, PMID 39020305
2023 (1), 2025 (1)