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Combined Ranibizumab and Iluvien for Diabetic Macular Oedema

NCT03784443 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-10-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Iluvien 0.19 MG Drug Implant

Fluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit

DRUG

Ranibizumab Injection [Lucentis]

Monthly PRN intravitreal injections

PROCEDURE

Sham Intravitreal Injection

Sham injection without penetrating needle and without drug delivery at baseline visit.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Richard Cheong-Leen · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-09-01
Completion
2023-09-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784443 on ClinicalTrials.gov