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

Conditions: retinitis pigmentosa
MedDRA version: 9.1Level: LLTClassification code 10038914Term: Retinitis pigmentosa
MedDRA version: 9.1Level: PTClassification code 10038914Term: Retinitis pigmentosa

Registration Number: EUCTR2008-004561-26-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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