Retinitis Pigmentosa associated Cystoid Macular Oedema MedDRA version: 18.1 Level: PT Classification code 10038914 Term: Retinitis pigmentosa System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Eylea
Product Name: Eylea
Product Code: n/a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aflibercept
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 28 days following the last visit of the last recruited patient in the study. The last visit of the last recruited patient in the study is defined as 12 months after they received their first intravitreal injection of Eylea.;Primary end point(s): To report mean Central Macular Thickness (CMT) at 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months.;Main Objective: To report mean Central Macular Thickness (CMT) at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months.; Secondary Objective: To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol at between baseline and six months, and baseline and twelve months. To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and twelve months. To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months. To report mean macular volu | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To report mean Central Macular Thickness (CMT) at 6 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months. To report mean change in Central Macular Thickness (CMT) as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months. To report the mean BCVA ETDRS letter score at 6 and 12 months in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months. To report the mean change in BCVA ETDRS letter score in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months, and baseline and twelve months. To report mean macular volume at 6 and 12 months as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six months and baseline and twelve months. To report mean change in macular volume as measured with SDOCT in eyes of patients with Retinitis Pigmentosa associated with cystoid macular oedema treated with three loading doses of Eylea at monthly intervals followed by a treat and extend protocol between baseline and six mon | — |
Countries
United Kingdom
Contacts
Public ContactGisela Barreto
Moorfields Eye Hospital
Outcome results
None listed