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

Primary Purpose

Macular Oedema, Retinitis Pigmentosa

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Aflibercept

About this trial

This is an interventional treatment trial for Macular Oedema focused on measuring Macular Oedema Retinitis Pigmentosa

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept (Eylea)

Arm 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.

Outcomes

Primary Outcome Measures

The efficacy of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)

Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months will assess the efficacy of the study; the number of Participants With Abnormal mean central macular thickness values.

The safety of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)

Safety will be assessed by the Adverse Events that are related to treatment and Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) to assess if Eylea has reduced fluid accumulation in the retina.

Secondary Outcome Measures

The mean central macular thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 months

The mean change in Central Macular Thickness on Spectral Domain Optical Coherence tomography (SD-OCT) from baseline to 6 months and baseline to 12 months

The mean Best Corrected Visual Acuity (BCVA) using the ETDRS visual acuity chart at 6 and 12 months

The mean change in ETDRS BCVA from baseline to 6 months and baseline to 12 months

The mean macular volume on SDOCT at 6 and 12 months

The mean change in macular volume on SDOCT from baseline to 6 months and baseline to 12 months

Report all Adverse Events and Serious Adverse Events

The mean retinal sensitivity using microperimetry at 6 and 12 months

The mean change in retinal sensitivity using microperimetry from baseline to 6 months and baseline to 12 months

The mean number of intravitreal injections administered

Full Information

NCT ID

NCT02661711

First Posted

January 13, 2016

Last Updated

September 13, 2016

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02661711

Brief Title

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

Acronym

AMOUR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Oedema, Retinitis Pigmentosa

Keywords

Macular Oedema Retinitis Pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aflibercept (Eylea)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea

Intervention Description

2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), 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 where there is no reduction in macula oedema compared with the previous visit. Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye.

Primary Outcome Measure Information:

Title

The efficacy of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)

Description

Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months will assess the efficacy of the study; the number of Participants With Abnormal mean central macular thickness values.

Time Frame

baseline to 12 months

Title

The safety of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)

Description

Time Frame

baseline to 12 months

Secondary Outcome Measure Information:

Title

The mean central macular thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 months

Time Frame

Baseline to 6 months

Title

The mean change in Central Macular Thickness on Spectral Domain Optical Coherence tomography (SD-OCT) from baseline to 6 months and baseline to 12 months

Time Frame