Combined Ranibizumab and Iluvien for Diabetic Macular Oedema

Sponsor
Imperial College London
Study ID
NCT03784443
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Iluvien 0.19 MG Drug Implant — DRUG
    Fluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit
  • Ranibizumab Injection [Lucentis] — DRUG
    Monthly PRN intravitreal injections
  • Sham Intravitreal Injection — PROCEDURE
    Sham injection without penetrating needle and without drug delivery at baseline visit.

Study Details

This trial investigated whether adding Iluvien sustained release steroid intravitreal eye implant at the beginning of regular anti-VEGF (anti Vascular Endothelial Growth Factor) intravitreal eye injection treatment for diabetic macular oedema would improve disease stability and reduce the need for regular anti-VEGF intravitreal eye injections over first two years. Diabetic macular oedema, accumulation of microscopic fluid at the back of the eye, is a major cause of poor vision in patients with diabetes. This is a double mask randomized control multisite trial, to be conducted at 10 NHS hospital eye clinics in England.

Key Dates

First listed
Dec 21, 2018
Start date
Sep 1, 2019
Status verified
Sep 2023
Primary completion
Sep 1, 2022
Completion
Sep 1, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Iluvien Arm
    Participants assigned to the Iluvien treatment arm will receive Iluvien 0.19 MG Drug Implant to the study eye under aseptic condition at baseline visit with monthly Ranibizumab Injection \[Lucentis\] for first three visits followed by monthly Ranibizumab Injection \[Lucentis\] PRN.
  • Sham Comparator: Control Arm
    To maintain double-masking, participants assigned to the control arm will receive Sham Intravitreal Injection at the baseline visit with monthly Ranibizumab Injection \[Lucentis\] for first three visits followed by monthly Ranibizumab Injection \[Lucentis\] PRN.

Primary Outcome Measure

Number of Lucentis Injections received in the study eye [ Time Frame: 24 months ]

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