Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study (AMOUR)
Macular Oedema, Retinitis Pigmentosa
About this trial
This is an interventional treatment trial for Macular Oedema focused on measuring Macular Oedema Retinitis Pigmentosa
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.
Sites / Locations
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Experimental
Aflibercept (Eylea)
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.