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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003723-65 | EudraCT Number |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Michel Michaelides, Professor | Moorfields Eye Hospital, Institute of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32041720 | Derived | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Intravitreal Aflibercept for RP-CMO | 30 patients recruited for this study, all of which receive the active drug, aflibercept |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravitreal Aflibercept for RP-CMO | 30 patients recruited for this study, all of which receive the active drug, aflibercept |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | Microns | at 12 months | eyes | eyes |
|
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Up to 17 months for the study duration.
Systematic collection at every patient visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept for RP-CMO | This arm received Aflibercept for RP-CMO | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sub-acute reduction of vision | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular adverse events | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tumelo Kaminskas | Moorfields Eye Hospital | 02072533411 | 2036 | moorfields.resadmin@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 26, 2015 | Jun 25, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2015 | Jun 25, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2016 | Jun 25, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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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).
| 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). | at 6 months and at 12 months |
| The Mean Macular Volume on SDOCT at 6 and 12 Months | 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 | baseline to 6 months and baseline to 12 months |
| Report All Adverse Events and Serious Adverse Events | 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 | 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 | From baseline to 6 months and baseline to 12 months |
| The Mean Number of Intravitreal Injections Administered | 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 | at 6 months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| eyes |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Microns | baseline to 6 months and baseline to 12 months | eyes | eyes |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | ETDRS letters | baseline to 6 months and baseline to 12 months | eyes | eyes |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | ETDRS letters | at 6 months and at 12 months | eyes | eyes |
|
|
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| Secondary | The Mean Macular Volume on SDOCT at 6 and 12 Months | Posted | Mean | Standard Deviation | millimeters cubed | baseline to 6 months and baseline to 12 months | eyes | eyes |
|
|
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| Secondary | The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months | Posted | Mean | Standard Deviation | millimeters cubed | baseline to 6 months and baseline to 12 months | eyes | eyes |
|
|
|
| Secondary | Report All Adverse Events and Serious Adverse Events | Posted | Number | participants | From date of first injection for first patient to the end of the study (17 months) | eyes | eyes |
|
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| Secondary | The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months | Posted | Mean | Standard Deviation | decibels | At 6 months and at 12 months | eyes | eyes |
|
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| Secondary | The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months | Posted | Mean | Standard Deviation | decibels | From baseline to 6 months and baseline to 12 months | eyes | eyes |
|
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| Secondary | The Mean Number of Intravitreal Injections Administered | Posted | Median | Inter-Quartile Range | injections | 17 months (from first patient first visit to last patient last visit) | eyes | eyes |
|
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| Secondary | 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 | 29 | Posted | Mean | Standard Deviation | micron | at 6 months |
|
|
|
| 30 |
| 1 |
| 30 |
| 26 |
| 30 |
| Systemic adverse event | General disorders | Systematic Assessment | Including anything reported by the patient at any time throughout the duration of the study, for example: bad back, feeling low, viral illness, bitten by mosquito, etc. |
|
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| D015785 |
| Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |