A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa.

Phase 1

• Conditions: Retinitis Pigmetosa.; MedDRA version: 19.0 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2016-002523-28-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-05
• Study Completion: 2016-10-20
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1

Inclusion Criteria

Adult patients with retinitis pigmentosa and signs of intraocular inflammation (vitreous cells, cataract, epiretinal membrane, intraretinal oedema, clinically significant migration of pigment cells into the retina??).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Patients in whom Fluocinolone Acetonide is contraindicated (prior infectious eye disease, glaucoma or ?steroid induced ocular hypertension). ?
?2.? Patients with a clinically apparent asymmetric expression of their retinopathy (as determined by an experienced retina physician).?
?3.? High ametropia (greater than ±6D) to avoid complications of cataract surgery should it be ?necessary.?
?4.? Patients with planned intraocular surgery within the study period.?
5. Patients with dense cataract precluding adequate fundus imaging.
6. Female patients who are pregnant or breastfeeding. Female patients of child-bearing age should ensure an adequate contraceptive measure is used.
7. Patients known to require other forms of systemic immunosuppression within the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified