Prospective non-randomised pilot study looking at the safety and efficacy of a drug called Eylea for patients with an eye condition called Retinitis Pigmentosa, that also have swelling at the back of the eye

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2015-003723-65-GB
• Date of registration: 06/01/2016
• Prospective Registration: Yes
• Primary sponsor: Moorfields Eye Hospital
• Public title: Prospective non-randomised pilot study looking at the safety and efficacy of a drug called Eylea for patients with an eye condition called Retinitis Pigmentosa, that also have swelling at the back of the eye
• Scientific title: Aflibercept (Eylea®) for macular oedema associated with underlying Retinitis Pigmentosa (AMOUR) - AMOUR
• Date of first enrolment: 12/01/2016
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003723-65
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• 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: Gisela Barreto
• Affiliation: Moorfields Eye Hospital

• Name: Gisela Barreto
• Affiliation: Moorfields Eye Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
1) At least 16 years of age
2) Unilateral or Bilateral CMO (the worse eye only will be treated – defined as the eye with a greater central macular thickness (CMT) on OCT)
3) No previous oral treatment for CMO for last 3 months
4) No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months
5) No previous topical treatment for CMO in the study eye for last 1 month
6) Central visual impairment that in the view of the Principal Investigator is due to CMO
7) BCVA better than 3/60.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1) Insufficient patient cooperation or media clarity to allow adequate fundus imaging
2) Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT that in the Principal Investigator’s opinion is highly likely to significantly limit the efficacy of intravitreal therapy
3) History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study
4) Any anti-VEGF treatment to study eye within 3 months
5) History of YAG capsulotomy performed within 3 months
6) Uncontrolled IOP > = 24 mmHg for ocular hypertension (on topical IOP lowering medications)
7) Advanced glaucoma (in the opinion of a glaucoma specialist)
8) Patients with active or suspected ocular or periocular infections
9) Patients with active severe intraocular inflammation
10) Patients with a new, untreated retinal tear or detachment,
11) Patients with a stage 3 or 4 macular hole
12) Thromboembolic event (MI/CVA/Unstable Angina) within 6 months
13) Pregnancy or family planned within 15 months
14) Females who are breast feeding
15) Known allergy or hypersensitivity to anti-VEGF products



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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Retinitis Pigmentosa associated Cystoid Macular Oedema
MedDRA version: 18.1 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Eylea
Product Name: Eylea
Product Code: n/a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aflibercept
CAS Number: 862111-32-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Primary end point(s): To report mean Central Macular Thickness (CMT) at 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.

Timepoint(s) of evaluation of this end point: 28 days following the last visit of the last recruited patient in the study. The last visit of the last recruited patient in the study is defined as 12 months after they received their first intravitreal injection of Eylea.

Main Objective: To report mean Central Macular Thickness (CMT) at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.

Secondary Objective: To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol at between baseline and six months, and baseline and twelve months.

To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.

To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report mean macular volume at 6 and 12 months as measured wi

Secondary Outcome(s)

Secondary end point(s): To report mean Central Macular Thickness (CMT) at 6 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.

To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report mean macular volume at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.

To report mean change in macular volume as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report all AEs and SAEs at any time point during the 12 month study of using intravitreal Eylea in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema.

To report the mean retinal sensitivity at 6 and 12 months using Microperimetry in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and basleine and twelve months.

To report the mean change in retinal sensitivity using Microperimetry in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months.

To report the mean number of intravitreal injections administered in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.

Timepoint(s) of evaluation of this end point: 28 days following the last visit of the last recruited patient in the study. The last visit of the last recruited patient in the study is defined as 12 months after they received their first intravitreal injection of Eylea.

Secondary ID(s)

MICM1014

Source(s) of Monetary Support

Bayer plc

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 20/06/2019
• Date Completed: 20/11/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003723-65/results