Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study

Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Study ID
NCT02661711
Phase
PHASE2
Status
Completed

Conditions

  • Macular Oedema
  • Retinitis Pigmentosa

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Mar 31, 2016
Status verified
Nov 2023
Primary completion
Oct 31, 2017
Completion
Oct 31, 2017

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 Months [ Time Frame: at 12 months ]

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