Macular OedemaPhase 2AMOURNCT02661711
Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study
A Phase 2 study testing Aflibercept in people with Macular Oedema and Retinitis Pigmentosa, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Macular Oedema, Retinitis Pigmentosa
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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.
- Conditions
- Macular Oedema, Retinitis Pigmentosa
- Being tested
- Aflibercept
- Keywords
- Macular Oedema Retinitis Pigmentosa
- Medical subject headings
- Macular Edema, Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea
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.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept (Eylea) | Experimental | 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. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months
Measured: at 12 months
Secondary outcomes (10)
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
Measured: 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
Mean Best Corrected Visual Acuity (BCVA) using the ETDRS visual acuity chart at 6 and 12 months.
BCVA is the best possible vision an eye can see with corrective lenses, measured using the ETDRS visual acuity chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m).
Measured: baseline to 6 months and baseline to 12 months
The Mean Change in ETDRS BCVA at 6 Months and at 12 Months
Mean ETDRS BCVA change at 6 months and at 12 months. BCVA is the best possible vision an eye can see with corrective lenses, measured using the ETDRS visual acuity chart. The ETDRS score is calculated as the total number of letters correctly read at 4m from the chart plus 30 (if 20 or more letters can be read at 4m).
Measured: at 6 months and at 12 months
The Mean Macular Volume on SDOCT at 6 and 12 Months
Measured: baseline to 6 months and baseline to 12 months
The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months
Measured: baseline to 6 months and baseline to 12 months
Report All Adverse Events and Serious Adverse Events
Measured: From date of first injection for first patient to the end of the study (17 months)
The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months
Measured: At 6 months and at 12 months
The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months
Measured: From baseline to 6 months and baseline to 12 months
The Mean Number of Intravitreal Injections Administered
Measured: 17 months (from first patient first visit to last patient last visit)
The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months
The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Michel Michaelides, Professor, Principal investigator, Moorfields Eye Hospital, Institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661711
- Sponsor's protocol ID
- MICM1014
- Other IDs
- 2015-003723-65, 2015
- Acronym
- AMOUR
- Status last verified
- Nov 2023
- First submitted
- 13 Jan 2016
- Last updated
- 6 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual patient data will not be disclosed publically, all the data will be anonymised and analysed in accordance with the Data Protection Act
Publications
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.
PubMed 32041720
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02661711
- Acronym / sponsor ID
- AMOUR / MICM1014
- Conditions
- Macular Oedema, Retinitis Pigmentosa
- Keywords
- Macular Oedema Retinitis Pigmentosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Posted 6 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept (Eylea) | Experimental | Drug: AfliberceptAll 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAlso: Eylea2mg 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. | Drug | Aflibercept (Eylea) |
Primary outcome
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months
Time frame: at 12 months
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months
10 secondary outcomes
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
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
The Mean Change in ETDRS BCVA at 6 Months and at 12 Months
Time frame: at 6 months and at 12 months
The Mean Macular Volume on SDOCT at 6 and 12 Months
Time frame: baseline to 6 months and baseline to 12 months
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
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)
The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months
Time frame: At 6 months and at 12 months
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
The Mean Number of Intravitreal Injections Administered
Time frame: 17 months (from first patient first visit to last patient last visit)
The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months
Time frame: at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32041720Strong 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.
- Individual participant dataSharing planned: No. Individual patient data will not be disclosed publically, all the data will be anonymised and analysed in accordance with the Data Protection Act
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Michaelides, Professor principal investigator
Moorfields Eye Hospital, Institute of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept in people with Macular Oedema and Retinitis Pigmentosa, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.