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

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2016-002523-28-GB
• Date of registration: 05/07/2016
• Prospective Registration: Yes
• Primary sponsor: Moorfields Eye Hospital
• Public title: A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa.
• Scientific title: A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa - Iluvien for IRD
• Date of first enrolment: 16/09/2016
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002523-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: control is the fellow (untreated) eye If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: fellow (untreated) eye Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

United Kingdom

Contacts

• Name: Natasha Ajraam, R&D
• Affiliation: Moorfields Eye Hospital

• Name: Natasha Ajraam, R&D
• Affiliation: Moorfields Eye Hospital

Key inclusion & exclusion 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:
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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

Retinitis Pigmetosa.
MedDRA version: 19.0 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Iluvien
Product Name: Iluvien
Product Code: n/a
Pharmaceutical Form: Implant
INN or Proposed INN: Fluocinolone Acetonide
CAS Number: 67-73-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.19-

Primary Outcome(s)

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.

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

Primary end point(s): Primary 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 degree macula centred image (mm2). (2) Area within the ring of hyperautofluorescence (outer edge taken as the limit if a broad band).
Visual Field: Change in size of V4e isopter area over 36 months.

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

Secondary Outcome(s)

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

Secondary ID(s)

KHAK1001

Source(s) of Monetary Support

Alimera Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 14/03/2019
• Date Completed: 20/10/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002523-28/results