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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
Sponsored by
Moorfields Eye Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 13, 2016
Last Updated
September 13, 2016
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Bayer
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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
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.
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
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.
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
baseline to 6 months and baseline to 12 months
Title
The mean Best Corrected Visual Acuity (BCVA) using the ETDRS visual acuity chart at 6 and 12 months
Time Frame
baseline to 6 months and baseline to 12 months
Title
The mean change in ETDRS BCVA from baseline to 6 months and baseline to 12 months
Time Frame
baseline to 6 months and baseline to 12 months
Title
The mean macular volume on SDOCT at 6 and 12 months
Time Frame
baseline to 6 months and baseline to 12 months
Title
The mean change in macular volume on SDOCT from baseline to 6 months and baseline to 12 months
Time Frame
baseline to 6 months and baseline to 12 months
Title
Report all Adverse Events and Serious Adverse Events
Time Frame
From date of first injection for first patient to the end of the study (17 months)
Title
The mean retinal sensitivity using microperimetry at 6 and 12 months
Time Frame
At 6 months and at 12 months
Title
The mean change in retinal sensitivity using microperimetry from baseline to 6 months and baseline to 12 months
Time Frame
From baseline to 6 months and baseline to 12 months
Title
The mean number of intravitreal injections administered
Time Frame
17 months (from first patient first visit to last patient last visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Michaelides, Professor
Organizational Affiliation
Moorfields Eye Hospital, Institute of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual patient data will not be disclosed publically, all the data will be anonymised and analysed in accordance with the Data Protection Act
Citations:
PubMed Identifier
32041720
Citation
Strong SA, Peto T, Bunce C, Xing W, Georgiou M, Esposti SD, Kalitzeos A, Webster A, Michaelides M. Prospective exploratory study to assess the safety and efficacy of aflibercept in cystoid macular oedema associated with retinitis pigmentosa. Br J Ophthalmol. 2020 Sep;104(9):1203-1208. doi: 10.1136/bjophthalmol-2019-315152. Epub 2020 Feb 10.
Results Reference
derived

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

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