A Phase 2/3 interventional study of Iluvien 0.19 MG Drug Implant and Ranibizumab Injection [Lucentis] in Diabetic Macular Edema and Diabetes, sponsored by Imperial College London. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Imperial College London · Phase 2/3, Interventional, and Treatment
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.
This study will recruit 58 participants in a double-masked, multi-centre, sham-controlled clinical trial. Participants will receive Iluvien implantation or sham implantation (masked) with a concomitant intravitreal injection of ranibizumab at baseline with an allocation ratio of 1:1. This is followed by regular monthly clinic review and repeat intravitreal ranibizumab injections to the study eye according to a PRN (pro re nata) treatment protocol.
This trial aims to evaluate whether Iluvien implantation in addition to standard anti-VEGF injection treatment for diabetic macular oedema in pseudophakic eyes will show similar visual acuity outcomes but with an improved reduction in CRT (Central Retinal Thickness) while reducing the average number of intravitreal injections during the first 2 years of treatment, due to the continual micro-dosing of Iluvien therapy.
Participants meeting all the eligibility criteria will be randomized to either Iluvien implant or sham implant procedure with an allocation ratio of 1:1. Participants assigned to either treatment arms will receive intravitreal injection of ranibizumab after Iluvien implantation or sham implantation at the same baseline visit.
To maintain double-masking, participants assigned to the control arm will receive sham implantation. This will be performed with an empty Luer Lock Syringe without a needle attached to it, that will not penetrate the eye nor deliver any drug. Patients assigned to either treatment arm will receive ranibizumab intravitreal injection to the study eye at baseline 30 minutes after the Iluvien or sham implantation. The sham injection should be performed by the unmasked investigator. The unmasked investigator should not be involved in any patient assessment in the study.
Participants will be followed up monthly for 2 years. Participants from both arms will receive compulsory Ranibizumab injection during the first three monthly visit and followed by monthly Ranibizumab as per PRN protocol. The end of study visit should take place at 104 weeks from the baseline visit.
Visual acuity measurement should be performed by trial certified optometrist according to the standard ETDRS (Early Treatment of Diabetic Retinopathy Study) protocol. This is to be conducted in certified examination rooms.
Spectral domain OCT (Optical Coherence Tomography) should be used to assess diabetic macular oedema and optic disc morphology at each visit. The OCT viewer software should be able to provide objective retinal thickness measurement of the central 1mm subfield thickness. Technicians should check for segmentation errors with every OCT scan and make appropriate manual adjustments.
OCT machines and designated technicians at each site will be certified prior to study commencement. Patients must always be assessed using the same OCT model.
7-View Fundus Photography and Fluorescein Angiography (FA) will be performed at the screening visit to confirm the diagnosis of diabetic macular oedema and assess diabetic retinopathy.
Additional FAs may be undertaken during subsequent visits should the investigator believe that there is a clinical need for it. Investigators at each local site are responsible for FA and OCT image interpretation. There will be no centralized image reading centre involved in this study.
IOP (Intraocular Pressure) measurement should be performed with Goldman tonometry either with undilated or dilated pupils.
The primary outcome analysis will be performed to test the differences in the average number of intravitreal injections between the two treatment arms up to month 24. This will be carried out according to an intent to treat principle.
The change of visual acuity from baseline to month 24 will be tested for non-inferiority against the control arm. We will analyze the stability of visual acuity and CRT using AUC (Area Under Curve) Analysis and estimate the average cost of resources utilization for both treatment arms.
Methods of dealing with missing data will follow established techniques, using multiple imputation to impute missing data. If necessary sensitivity analyses will be undertaken to examine the dependence of the results on the method of imputation.
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General
Ocular
Exclusion Criteria:
General
Ocular
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.
Drug: Iluvien 0.19 MG Drug Implant · Drug: Ranibizumab Injection [Lucentis]
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.
Drug: Ranibizumab Injection [Lucentis] · Procedure: Sham Intravitreal Injection
Fluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit
Also known as: Fluocinolone Acetonide Implant
Monthly PRN intravitreal injections
Also known as: Lucentis
Sham injection without penetrating needle and without drug delivery at baseline visit.
Also known as: Sham Injection with Luer Lock Syringe
Number of Lucentis Injections received in the study eye
The total number of Lucentis injections needed over 24 months following the intravitreal injection PRN protocol
Time frame: 24 months
Change in visual acuity
Change in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity from baseline to month 24
Time frame: Month 24
Maintaining at least 20/40 vision
Percentage of patients that achieve or maintain 20/40 vision
Time frame: Month 24
Proportion of participants with vision loss
Proportion of participants losing 5, 10, 15 ETDRS letters or more
Time frame: Month 24
Proportion of participants with visual gain
Proportion of participants gaining at least 5, 10, 15 ETDRS letters or more
Time frame: Month 24
Stability of vision
Stability of visual acuity over 24 months using Area Under Curve Analysis (AUC)
Time frame: Over 24 months
Central retinal thickness
Central retinal thickness (CRT) change as measured by Spectral Domain OCT
Time frame: Month 24
CRT stability
Stability of CRT over 24 months using AUC analysis
Time frame: Over 24 months
Retinal thickness variability
The difference between min and max retinal thickness
Time frame: Over 24 months
Change in Diabetic Retinopathy Severity
Measured using the ETDRS DRSS (Diabetic Retinopathy Severity Score)
Time frame: Between baseline and month 24
Number of focal laser treatments
Number of focal laser treatments
Time frame: Over 24 months
No study locations are listed for this record.
Plan to share: Undecided
This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Imperial College London