EUCTR2015-003723-65-GBActive, not recruitingPhase 1
Aflibercept (Eylea®) for macular oedema associated with underlying Retinitis Pigmentosa (AMOUR) - AMOUR
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Moorfields Eye Hospital
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1) At least 16 years of age
- •2) Unilateral or Bilateral CMO (the worse eye only will be treated – defined as the eye with a greater central macular thickness (CMT) on OCT)
- •3) No previous oral treatment for CMO for last 3 months
- •4) No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months
- •5) No previous topical treatment for CMO in the study eye for last 1 month
- •6) Central visual impairment that in the view of the Principal Investigator is due to CMO
- •7) BCVA better than 3/60.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •1) Insufficient patient cooperation or media clarity to allow adequate fundus imaging
- •2) 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
- •3) History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study
- •4) Any anti-VEGF treatment to study eye within 3 months
- •5) History of YAG capsulotomy performed within 3 months
- •6) Uncontrolled IOP > = 24 mmHg for ocular hypertension (on topical IOP lowering medications)
- •7) Advanced glaucoma (in the opinion of a glaucoma specialist)
- •8) Patients with active or suspected ocular or periocular infections
- •9) Patients with active severe intraocular inflammation
- •10) Patients with a new, untreated retinal tear or detachment,
- •11) Patients with a stage 3 or 4 macular hole
- •12) Thromboembolic event (MI/CVA/Unstable Angina) within 6 months
- •13) Pregnancy or family planned within 15 months
- •14) Females who are breast feeding
- •15) Known allergy or hypersensitivity to anti-VEGF products
Investigators
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