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

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-003723-65-GB
• Lead Sponsor: Moorfields Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-06
• Study Completion: 2018-11-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

Study & Design

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