erve Growth Factor eye drops as a novel treatment for patients with Retinitis Pigmentosa.

Conditions: Retinitis pigmentosa with cystoid macular edema
MedDRA version: 17.0Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 100000004853
MedDRA version: 17.0Level: PTClassification code 10038914Term: Retinitis pigmentosaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2014-000385-22-IT

Lead Sponsor: Ospedale San Raffaele di Milano

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. Patients between 18 and 60 years of age.
2. Patients with typical orms of RP characterized by the following
clinical features:
a) classic fundus appearance (i.e. intraretinal pigment deposits,thinning and atrophy of the RPE in the mid- and far peripheral retina, with relative RPE preservation in the macula, waxy
pallor of the optic disc, attenuation of the retinal vessels)
b) reduced and delayed ERG responses
c) visual field constriction
and/or atypical forms of RP:
The atypical form of RP is characterized by early onset (first decade) or syndromic forms of RP (eg paravenous sector pericentral or unilateral RP, Leber congenital amaurosis, Resfum disease, Usher syndrome, Bardet - Biedl, etc. ).
3. presence of macular edema documented by OCT (macular thickness greater than 250 um) lasting for at least 3 months and not in treatment for at least 1 month;
4 Best corrected distance visual acuity (BCDVA) between 20/100 (2/10 or 0.1 logMAR) and 20/25 (8/10 or +0.7 logMAR) , near vision lower than second character in either eye.
5. Absence of other confounding ocular diseases.
6. Only patients who satisfy all Informed Consent requirements may be
included in the study. The patient and/or his/her impartial witness must
read, sign and date the Informed Consent document before any
studyrelated procedures are performed. The Informed Consent form signed by patients and/or impartial witness must have been approved by the IEC for the current study.
7. Patients must have the ability and willingness to comply with study
procedures.
Are the trial subjects under 18? no
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 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Presence of macular edema associated with diabetes , choroidal neovascularization or after eye surgery.
2 . Patients with diabetes mellitus
3 . History of any ocular surgery (including laser or refractive surgical
procedures) in either eye within the 90 days before study enrolment.
Ocular surgery will not be allowed during the study treatment period and
elective ocular surgery procedure.
4. Evidence of an active ocular infection.
5. History of uveitis or evidence of intraocular inflammation in either eye.
6. History or evidence of glaucoma or an IOP greater than or equal 21
mmHg in either eye at the time of study enrollment
7. Anterior segment abnormalities or media opacities obscuring the view
of the posterior pole in either eye.
8. Treatment with corticosteroids (systemic, periocular or intravitreal)
) in either eye within 90 days of study enrollment.
9. Use of any topical medication other than the study medication for the
treatment of ocular diseases with the exception of artificial tears during the study period.
10. Presence or history of any ocular or systemic disorder or condition
that might significantly limit visual acuity or the visual field, hinder the
efficacy of the study treatment or its evaluation, could possibly interfere
with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trail procedures.
11. Known hypersensitivity to one of the components of the study or
procedural medications.
12. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit.
13. History of drug, medication or alcohol abuse or addiction.
14. Females of childbearing potential (those who are not surgically
sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
a. are currently pregnant or,
b. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
c. intend to become pregnant during the study treatment period or,
d. are breast-feeding or,
e. not willing to use highly effective birth control measures, such as:
Hormonal contraceptives – oral, implanted, transdermal, or injected
and/or mechanical barrier methods – spermicide in conjunction with a
barrier such as a condom or diaphragm or IUD during the entire course
of and 30 days after the study treatment periods.