Inner Retinal Dysfunction of the Cone System in Inherited Photoreceptor Degenerations: A Study of Disease Sequence and Assessment of Novel Therapeutic Strategies. - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004561-26-IT

Enrollment

180

Registered

2008-11-11

Start date

2009-06-01

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

retinitis pigmentosa MedDRA version: 9.1 Level: LLT Classification code 10038914 Term: Retinitis pigmentosa MedDRA version: 9.1 Level: PT Classification code 10038914 Term: Retinitis pigmentosa

Interventions

Product Name: Nerve Growt Factor - 2.5S Pharmaceutical Form: Eye drops, solution CAS Number: 93928-24-6 Current Sponsor code: N 6009 Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. diagnosi di RP tipica con pattern di disfunzione retinica tipo ?rod-cone?, determinata da esami elettroretinografici con cupola Ganzfeld e dalla perimetria con adattamento al buio, e dal classico aspetto del fondo oculare, 2. funzione centrale retinica parzialmente conservata (campo visivo valutato con mira V/4e > 30, acuita` visiva secondo ETDRS corretta > 20/40), 3. genotipo conosciuto o in valutazione, 4. almeno quattro valutazioni cliniche di follow-up nei precedenti tre anni, 5. assenza di opacita` dei mezzi diottrici, 6. assenza di patologie oculari concomitanti (e.g. glaucoma, ambliopia) o di patologie sistemiche Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Typical RP with a rod-cone pattern of retinal dysfunction, as determined by standard Ganzfeld electroretinography and dark-adapted fundus perimetry, and classic fundus appearance, 2. Relatively preserved central retinal function (visual field by Goldmann V/4e > 30, corrected ETDRS visual acuity > 20/40), 3. Known genotype or genotype under study, 4. At least four follow-up clinical examination over the past three years, 5. No or minimal ocular media opacities, 6. No concomitant ocular (e.g. glaucoma, amblyopia) or systemic diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: to test the hypothesis that an intrinsic, fundamental sequence of adverse events occurs in the inner retina of all individuals affected by inherited photoreceptor degenerations, and that this pathological sequence may be delayed by therapeutic approaches based on neuroprotection.;Secondary Objective: ND;Primary end point(s): ND	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026