Retinitis Pigmetosa. MedDRA version: 19.0 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Iluvien
Product Name: Iluvien
Product Code: n/a
Pharmaceutical Form: Implant
INN or Proposed INN: Fluocinolone Acetonide
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To describe the anatomical and functional changes occurring in treated and control eyes over a 36-month period. Technical outcome measures = OCT: (1) Change in area of ellipsoid zone integrity (mm2) at the macula. (2) Change in outer retinal thickness across the macula. (3) Change in subfoveal choroidal thickness (mm). FAF: (1) Change in area demonstrating “loss of AF” on standard 55° macula centred image (mm2). (2) Area within the ring of hyperautofluorescence (mm2). Visual Field: Change in size of V4e isopter area. ; Secondary Objective: 1. To describe further anatomical and functional changes occurring in treated and control eyes over 36 months. Technical outcome measures = Retinal Oximetry: Change in oxygen saturation and vessel calibre in retinal venules and arterioles taken at predetermined retinal loci. ERG: Change in all ISCEV electrophysiological parameters - PERG amplitude (P50, N95), rod-specific B wave amplitude, FFERG A and B wave amplitudes and timing, 30Hz flicker amplitude and latency, extent of multifocal ERG change. The hand-held ERG (RETeval) will be used to monitor 30Hz flicker. Microperimetry: Change in mesopic and scotopic threshold sensitivities at predetermined retinal loci. Change in area under the “hill of vision”. Adaptive optics slit lamp ophthalmoscopy: Change in photoreceptor outer segment morphology (Cone density, ratio of hexagonal Voronoi domain, and average nearest neighbour distance (NND)/expected NND - mean value of two independent graders). 2. To study the safety profile ; Timepoint(s) of evaluation of this end point: Baseline (month 0) Week 2 (safety check of intraocular pressure) Month 4 Month 8 Month 12 Month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Retinal Oximetry: Change in oxygen saturation and vessel calibre in retinal venules and arterioles taken at predetermined retinal loci. ERG: Change in all ISCEV electrophysiological parameters - PERG amplitude (P50, N95), rod-specific B wave amplitude, FFERG A and B wave amplitudes and timing, 30Hz flicker amplitude and latency, extent of multifocal ERG change. The hand-held ERG (RETeval) will be used to monitor 30Hz flicker. Microperimetry: Change in mesopic and scotopic threshold sensitivities at predetermined retinal loci. Change in area under the “hill of vision”. Adaptive optics slit lamp ophthalmoscopy: Change in photoreceptor outer segment morphology (Cone density, ratio of hexagonal Voronoi domain, and average nearest neighbour distance (NND)/expected NND - mean value of two independent graders). The safety profile over 36 months of an intravitreal steroid implant (Fluocinolone Acetonide, 0.19mg) in adult patients with retinitis pigmentosa. Outcome measures: Number of cases requiring treatment for either (a) ocular hypertension or glaucoma, (b) cataract or (c) posterior segment disease (retinal detachment, tear or endophthalmitis). ; Timepoint(s) of evaluation of this end point: Baseline (month 0) Week 2 (safety check of intraocular pressure) Month 4 Month 8 Month 12 Month 24 Month 36 | — |
Countries
United Kingdom
Contacts
Public ContactNatasha Ajraam, R&D
Moorfields Eye Hospital
Outcome results
None listed