Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study

Moorfields Eye Hospital NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Macular Oedema; Retinitis Pigmentosa

Treatments: Drug: Aflibercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02661711

2015-003723-65 (EudraCT Number)

MICM1014

Details and patient eligibility

About

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).

Full description

This is a 17 month phase II therapeutic exploratory trial in Cystoid Macular Oedema (CMO) with underlying Retinitis Pigmentosa (RP). The study design is a prospective, open-label, interventional non-randomised trial. All patients enrolled in the study will receive intravitreal injections of Aflibercept (Eylea).

There will be a 9 month recruitment window and patient participation will be for 12 months; 30 patients aged 16 years or older presenting in the Medical Retina and Genetics clinics at Moorfields Eye Hospital with Cystoid Macula Oedema (CMO) with underlying Retinitis Pigmentosa (RP) will be approached by the study team to discuss participation in the AMOUR study and be given a patient information leaflet. If patients decide to participate in the study they will be invited to the NIHR Moorfields Clinical Research Facility for a baseline screening where written informed consent will be given by the patient and various assessments will be performed to confirm eligibility.

Patients enrolled in the study will receive intravitreal injections of 2mg of 40mg/ml of Aflibercept (Eylea) solution in the study eye. In the first three months, patients will receive a loading dose of Aflibercept (Eylea) with one injection every four weeks. After the first three months, treatment frequency will follow a treat and extend protocol for up to 12 months from date of study enrolment. Extension from 4 weekly to 6,8,10 and 12 week follow up will occur when there is no further reduction in macula fluid compared to the previous visit. Patients will receive a minimum of 5 injections before being deemed as non-responders to treatment.

Imaging and assessments such as optical coherence tomography imaging, microperimetry and visual acuity will be used to assess response to treatment.

Enrollment: 30 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Aflibercept (Eylea)

Experimental group

Description:

All patients recruited to the study will receive 3 loading intravitreal injections of Aflibercept (Eylea) at monthly intervals followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow-up will occur when there is evidence of OCT stability in the view of the investigator i.e. there is no further reduction in macular fluid compared to the previous visit. All patients will receive 5 injections before considering them non-responders.

Treatment:

Drug: Aflibercept