Phase 2
N=30
Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study
Macular Oedema · Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT02661711 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
May 2024
Primary outcome: Primary: Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months — 413.4 Microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aflibercept (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months |
413.4 | — |
| 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 |
-46.2; -47.6 | — |
| SECONDARY The Mean Best Corrected Visual Acuity (BCVA) Using the ETDRS Visual Acuity Chart at 6 and 12 Months |
66.9; 68.0 | — |
| SECONDARY The Mean Change in ETDRS BCVA at 6 Months and at 12 Months |
3.1; 4.3 | — |
| SECONDARY The Mean Macular Volume on SDOCT at 6 and 12 Months |
7.9; 8.0 | — |
| SECONDARY The Mean Change in Macular Volume on SDOCT From Baseline to 6 Months and Baseline to 12 Months |
-0.3; -0.3 | — |
| SECONDARY Report All Adverse Events and Serious Adverse Events |
26; 1 | — |
| SECONDARY The Mean Retinal Sensitivity Using Microperimetry at 6 and 12 Months |
4.92; 4.93 | — |
| SECONDARY The Mean Change in Retinal Sensitivity Using Microperimetry From Baseline to 6 Months and Baseline to 12 Months |
-1.23; -1.09 | — |
| SECONDARY The Mean Number of Intravitreal Injections Administered |
7 | — |
| SECONDARY The Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 Months |
414.8 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02661711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.