Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dompé Farmaceutici S.p.A | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims at investigating the therapeutic potential of recombinant human Nerve Growth Factor ( rhNGF ) eye drops treatment in patients with Retinitis Pigmentosa (RP) associated with cystoid macular edema (CME) in a phase II, randomized, double-masked, controlled clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | rhNGF 180 µg/ml eye drops solution |
|
| control group | Placebo Comparator | vehicle eye drops solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhNGF 180 µg/ml eye drops solution | Drug | eye drops |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| macular thickness | assessed by ocular coherence tomography (OCT) | 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| visual field | mean deviation | 28 days of treatment, 1 month, 6 months and 12 months of follow-up |
| macular photoreceptors thickness | assessed by OCT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Presence of diabetes-related macular edema, or macular edema associated with other causes such as choroideal neovascularization or after the eye surgery.
patients with diabetes mellitus.
Patients who have performed eye surgery in the previous three months.
Evidence of an active eye infection.
previous uveitis or evidence of intraocular inflammation.
History or evidence of glaucoma or elevated intraocular pressure (IOP) greater than or equal to 21 mm Hg at baseline.
abnormalities of the anterior segment or media opacities that prevent the assessment of the posterior segment of te eye
The treatment with corticosteroids (systemic, periocular or intravitreal) from at least 3 months.
The use of any topical medication other than the study drug for the treatment of ocular pathologies.
Presence or history of any systemic or ocular disease or condition that may significantly limit of visual acuity or visual field, hindering the effectiveness of treatment in the study or its evaluation, or could interfere with the interpretation of The study results, or may be judged by the investigator incompatible with the visit program or with the procedures in the study.
Known hypersensitivity to study drug or drugs procedural.
Participation in another clinical study during the same period of this study or within 90 days of the screening visit / baseline.
History of drug use, illegal drugs or alcohol abuse or addiction.
Women of childbearing potential are excluded from participation in the study if they meet one of the following conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paolo Rama, MD | Ospedale San Raffaele. Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Milan | 20132 | Italy | |||
| Ospedale Sacco |
Not provided
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| ID | Term |
|---|---|
| C000647429 | cenegermin |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| vehicle eye drops | Drug | placebo |
|
|
| 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up |
| macular thickness | assessed by OCT | 1 month,3 months, 6 months and 12 months of follow-up |
| electroretinogram (ERG) | amplitudes | 28 days of treatment, 1 month, 6 months and 12 months of follow-up |
| visual acuity | 28 days of treatment,1 month,3 months, 6 months and 12 months of follow-up |
| contrast sensitivity | 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up |
| quality of life | 28 days of treatment, 1 month,3 months, 6 months and 12 months of follow-up |
| number of cystoid macular edema relapses | through study completion, up to 12 months of follow-up |
| number of drop out for inefficacy of the study treatment | through study completion, up to 12 months of follow-up |
| adverse events | through study completion, up to 12 months of follow-up |
| Milan |
| Italy |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008268 | Macular Degeneration |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |