Prospective Non-randomised Exploratory Study to Assess the Safety and Efficacy of Aflibercept (Eylea) in Cystoid Macular Oedema (CMO) Associated With Retinitis Pigmentosa (RP)

MICM1014

The purpose of this study is to assess the safety and efficacy of intravitreal injections of Aflibercept (Eylea) in treating Cystoid Macula Oedema (CMO) in patients with underlying Retinitis Pigmentosa (RP).

2016-03-01

2017-10-01

2017-10-01

Completed

Early phase I

30

Inclusion Criteria: * CMO in association with RP * \> 16 years of age * Unilateral or Bilateral CMO (the worse eye only will be treated - defined as the eye with a greater central macular thickness (CMT) on OCT) * No previous oral treatment for CMO for last 3 months * No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months * No previous topical treatment for CMO in the study eye for last 1 month * Central visual impairment that in the view of the Principal Investigator is due to CMO * BCVA better than 3/60 Exclusion Criteria: * Insufficient patient cooperation or media clarity to allow adequate fundus imaging. * 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. * History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study. * Any anti-VEGF treatment to study eye within 3 months. * History of YAG capsulotomy performed within 3 months. * Uncontrolled Intraocular pressure (IOP) \> = 24 mmHg for ocular hypertension (on topical IOP lowering medications) * Advanced glaucoma (in the opinion of a glaucoma specialist). * Patients with active or suspected ocular or periocular infections * Patients with active severe intraocular inflammation. * Patients with a new, untreated retinal tear or detachment * Patients with a stage 3 or 4 macular hole * Thromboembolic event (MI/CVA/Unstable Angina) within 6 months. * Pregnancy or family planned within 15 months * Females who are breast feeding * Known allergy or hypersensitivity to anti-VEGF products Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks after treatment discontinuation. The MHRA advise double contraception. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. Note: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-05-06