Diabetic Macular EdemaPhase 2/3CASSIENCT03784443
Combined Ranibizumab and Iluvien for Diabetic Macular Oedema
A Phase 2/3 study testing Iluvien 0.19 MG Drug Implant and Ranibizumab Injection [Lucentis] in people with Diabetic Macular Edema and Diabetes, run by Imperial College London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetes
- What is being tested?
- Iluvien 0.19 MG Drug Implant and Ranibizumab Injection [Lucentis]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General
- Willingness and the ability to provide informed consent.
- Ability and willingness to undertake all scheduled visits, assessment and treatment.
- Age 18 years or above.
- Documented diagnosis of diabetes mellitus (Type I or Type II) as per WHO (World Health Organization) criteria.
- Current regular use of oral anti-hyperglycaemia or insulin therapy.
Show all 13Show fewer
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the study duration of 24 months.
- Ocular
- Macular thickening due to Diabetic Macular Oedema (DMO) involving the centre of fovea as measured by Spectral Domain OCT with CRT of at least 400 microns.
- DMO confirmed by clinical examination and fundus fluorescein angiography.
- BCVA between 73 to 25 letters inclusive (Snellen equivalent to 6/12 to 6/96) as measured using ETDRS protocol at 4 meters.
- Pseudophakia in the study eye.
- Adequate ocular media clarity and pupillary dilatation allowing for posterior segment examination and OCT scanning.
Who cannot join
- General
- Cerebral vascular accident, transient ischaemic attack or myocardial infarction within 3 months prior to day 1 (baseline).
- Pregnancy or breastfeeding, or intention to become pregnant during the study.
- Participation in an investigational trial involving treatment with any drug or devices within 3 months prior to day 1 (baseline) and must not be enrolled in another investigational trial during their participation in this trial.
- Systemic anti-VEGF-base therapies within 3 months prior to day 1 (baseline).
- Ocular
Show all 20Show fewer
- History of prior intravitreal anti-VEGF therapy or steroid implant in the study eye.
- History of proliferative diabetic retinopathy.
- History of rubeosis or current rubeosis.
- History of neovascularization, tractional retinal detachment, retinal vein occlusion, or significant pre-retinal fibrosis distorting the macular architecture.
- History of retinal detachment or macular hole stage 3 or above.
- History of vitreoretinal surgery.
- Aphakia.
- History of glaucoma or uncontrolled ocular hypertension.
- Active or suspected ocular or periocular infection or inflammation, including viral diseases of the cornea, conjunctiva and retina, such as active epithelial herpes simplex keratitis (dendritic keratitis), varicella, mycobacterial infections, and fungal diseases.
- Panretinal Photocoagulation (PRP) laser treatment within 3 months prior to day 1.
- Macular laser (focal or grid) within 3 months prior to day 1.
- YAG (yttrium aluminium garnet) laser capsulotomy laser within 3 months prior to day 1.
- Any periocular steroid treatment within 6 months prior to day 1.
- Cataract operation within 3 months prior to day 1.
About this study
Official title: Combined Anti-VEGF Intravitreal Injections With Sustained Steroid Implantation for the Treatment of Diabetic Macular Oedema
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.
Read the detailed description
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.
- Conditions
- Diabetic Macular Edema, Diabetes
- Being tested
- Iluvien 0.19 MG Drug Implant, Ranibizumab Injection [Lucentis], Sham Intravitreal Injection
- Keywords
- Diabetes, Eye, Macular Oedema, Intravitreal Injection, Ranibizumab, Fluocinolone Acetonide
- Medical subject headings
- Diabetes Mellitus, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iluvien 0.19 MG Drug ImplantDrug
Also called Fluocinolone Acetonide Implant
Fluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit
Ranibizumab Injection [Lucentis]Drug
Also called Lucentis
Monthly PRN intravitreal injections
Sham Intravitreal InjectionProcedure or surgery
Also called Sham Injection with Luer Lock Syringe
Sham injection without penetrating needle and without drug delivery at baseline visit.
| Study group | Role | What they receive |
|---|---|---|
| Iluvien Arm | Active comparator | 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. Receives: Drug: Iluvien 0.19 MG Drug Implant; Drug: Ranibizumab Injection [Lucentis] |
| Control Arm | Sham comparator | 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. Receives: Drug: Ranibizumab Injection [Lucentis]; Procedure: Sham Intravitreal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (10)
Change in visual acuity
Change in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity from baseline to month 24
Measured: Month 24
Maintaining at least 20/40 vision
Percentage of patients that achieve or maintain 20/40 vision
Measured: Month 24
Proportion of participants with vision loss
Proportion of participants losing 5, 10, 15 ETDRS letters or more
Measured: Month 24
Proportion of participants with visual gain
Proportion of participants gaining at least 5, 10, 15 ETDRS letters or more
Measured: Month 24
Stability of vision
Stability of visual acuity over 24 months using Area Under Curve Analysis (AUC)
Measured: Over 24 months
Central retinal thickness
Central retinal thickness (CRT) change as measured by Spectral Domain OCT
Measured: Month 24
CRT stability
Stability of CRT over 24 months using AUC analysis
Measured: Over 24 months
Retinal thickness variability
The difference between min and max retinal thickness
Measured: Over 24 months
Change in Diabetic Retinopathy Severity
Measured using the ETDRS DRSS (Diabetic Retinopathy Severity Score)
Measured: Between baseline and month 24
Number of focal laser treatments
Number of focal laser treatments
Measured: Over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Why it stopped: Funder withdrawn funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double masking randomized control trial with 2 parallel treatment arms: intervention (Iluvien plus Ranibizumab) vs control (Sham plus Ranibizumab)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Cheong-Leen, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784443
- Sponsor's protocol ID
- P78912
- Acronym
- CASSIE
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2018
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Antonetti DA, Klein R, Gardner TW. Diabetic retinopathy. N Engl J Med. 2012 Mar 29;366(13):1227-39. doi: 10.1056/NEJMra1005073. No abstract available.
PubMed 22455417Bunce C, Wormald R. Causes of blind certifications in England and Wales: April 1999-March 2000. Eye (Lond). 2008 Jul;22(7):905-11. doi: 10.1038/sj.eye.6702767. Epub 2007 Mar 2.
PubMed 17332762Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.
PubMed 9627648Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
PubMed 22301125Virgili G, Parravano M, Menchini F, Evans JR. Anti-vascular endothelial growth factor for diabetic macular oedema. Cochrane Database Syst Rev. 2014 Oct 24;(10):CD007419. doi: 10.1002/14651858.CD007419.pub4.
PubMed 25342124Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2.
PubMed 18254088Goni FJ, Stalmans I, Denis P, Nordmann JP, Taylor S, Diestelhorst M, Figueiredo AR, Garway-Heath DF. Elevated Intraocular Pressure After Intravitreal Steroid Injection in Diabetic Macular Edema: Monitoring and Management. Ophthalmol Ther. 2016 Jun;5(1):47-61. doi: 10.1007/s40123-016-0052-8. Epub 2016 May 10.
PubMed 27164896Parrish RK 2nd, Campochiaro PA, Pearson PA, Green K, Traverso CE; FAME Study Group. Characterization of Intraocular Pressure Increases and Management Strategies Following Treatment With Fluocinolone Acetonide Intravitreal Implants in the FAME Trials. Ophthalmic Surg Lasers Imaging Retina. 2016 May 1;47(5):426-35. doi: 10.3928/23258160-20160419-05.
PubMed 27183546Funatsu H, Yamashita H, Ikeda T, Mimura T, Eguchi S, Hori S. Vitreous levels of interleukin-6 and vascular endothelial growth factor are related to diabetic macular edema. Ophthalmology. 2003 Sep;110(9):1690-6. doi: 10.1016/S0161-6420(03)00568-2.
PubMed 13129863Funatsu H, Yamashita H, Sakata K, Noma H, Mimura T, Suzuki M, Eguchi S, Hori S. Vitreous levels of vascular endothelial growth factor and intercellular adhesion molecule 1 are related to diabetic macular edema. Ophthalmology. 2005 May;112(5):806-16. doi: 10.1016/j.ophtha.2004.11.045.
PubMed 15878060Aiello LP. Angiogenic pathways in diabetic retinopathy. N Engl J Med. 2005 Aug 25;353(8):839-41. doi: 10.1056/NEJMe058142. No abstract available.
PubMed 16120866Wang K, Wang Y, Gao L, Li X, Li M, Guo J. Dexamethasone inhibits leukocyte accumulation and vascular permeability in retina of streptozotocin-induced diabetic rats via reducing vascular endothelial growth factor and intercellular adhesion molecule-1 expression. Biol Pharm Bull. 2008 Aug;31(8):1541-6. doi: 10.1248/bpb.31.1541.
PubMed 18670086Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England. Br J Ophthalmol. 2012 Mar;96(3):345-9. doi: 10.1136/bjo.2011.204040. Epub 2011 May 20.
PubMed 21602478Arevalo JF, Lasave AF, Wu L, Acon D, Farah ME, Gallego-Pinazo R, Alezzandrini AA, Fortuna V, Quiroz-Mercado H, Salcedo-Villanueva G, Maia M, Serrano M, Rojas S; Pan-American Collaborative Retina Study Group (PACORES). Intravitreal bevacizumab for diabetic macular oedema: 5-year results of the Pan-American Collaborative Retina Study group. Br J Ophthalmol. 2016 Dec;100(12):1605-1610. doi: 10.1136/bjophthalmol-2015-307950. Epub 2016 Feb 24.
PubMed 26912377Wells JA, Glassman AR, Ayala AR, Jampol LM, Bressler NM, Bressler SB, Brucker AJ, Ferris FL, Hampton GR, Jhaveri C, Melia M, Beck RW; Diabetic Retinopathy Clinical Research Network. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology. 2016 Jun;123(6):1351-9. doi: 10.1016/j.ophtha.2016.02.022. Epub 2016 Feb 27.
PubMed 26935357
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Anti-VEGF Intravitreal Injections With Sustained Steroid Implantation for the Treatment of Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT03784443
- Acronym / sponsor ID
- CASSIE / P78912
- Conditions
- Diabetic Macular Edema, Diabetes
- Keywords
- Diabetes, Eye, Macular Oedema, Intravitreal Injection, Ranibizumab, Fluocinolone Acetonide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funder withdrawn funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double masking randomized control trial with 2 parallel treatment arms: intervention (Iluvien plus Ranibizumab) vs control (Sham plus Ranibizumab)
| Arm | Type | Receives |
|---|---|---|
| Iluvien Arm | Active comparator | Drug: Iluvien 0.19 MG Drug Implant, Drug: Ranibizumab Injection [Lucentis]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. |
| Control Arm | Sham comparator | Drug: Ranibizumab Injection [Lucentis], Procedure: Sham Intravitreal InjectionTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- General
- Willingness and the ability to provide informed consent.
- Ability and willingness to undertake all scheduled visits, assessment and treatment.
- Age 18 years or above.
- Documented diagnosis of diabetes mellitus (Type I or Type II) as per WHO (World Health Organization) criteria.
Key exclusion criteria (20 listed)
- General
- Cerebral vascular accident, transient ischaemic attack or myocardial infarction within 3 months prior to day 1 (baseline).
- Pregnancy or breastfeeding, or intention to become pregnant during the study.
- Participation in an investigational trial involving treatment with any drug or devices within 3 months prior to day 1 (baseline) and must not be enrolled in another investigational trial during their participation in this trial.
- Systemic anti-VEGF-base therapies within 3 months prior to day 1 (baseline).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iluvien 0.19 MG Drug ImplantAlso: Fluocinolone Acetonide ImplantFluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit | Drug | Iluvien Arm |
| Ranibizumab Injection [Lucentis]Also: LucentisMonthly PRN intravitreal injections | Drug | Control Arm, Iluvien Arm |
| Sham Intravitreal InjectionAlso: Sham Injection with Luer Lock SyringeSham injection without penetrating needle and without drug delivery at baseline visit. | Procedure or surgery | Control Arm |
Primary outcome
Number of Lucentis Injections received in the study eye
Time frame: 24 months
The total number of Lucentis injections needed over 24 months following the intravitreal injection PRN protocol
10 secondary outcomes
Change in visual acuity
Time frame: Month 24
Maintaining at least 20/40 vision
Time frame: Month 24
Proportion of participants with vision loss
Time frame: Month 24
Proportion of participants with visual gain
Time frame: Month 24
Stability of vision
Time frame: Over 24 months
Central retinal thickness
Time frame: Month 24
CRT stability
Time frame: Over 24 months
Retinal thickness variability
Time frame: Over 24 months
Change in Diabetic Retinopathy Severity
Time frame: Between baseline and month 24
Number of focal laser treatments
Time frame: Over 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 22455417Antonetti DA, Klein R, Gardner TW. Diabetic retinopathy. N Engl J Med. 2012 Mar 29;366(13):1227-39. doi: 10.1056/NEJMra1005073. No abstract available.
- Background: PubMed 17332762Bunce C, Wormald R. Causes of blind certifications in England and Wales: April 1999-March 2000. Eye (Lond). 2008 Jul;22(7):905-11. doi: 10.1038/sj.eye.6702767. Epub 2007 Mar 2.
- Background: PubMed 9627648Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.
- Background: PubMed 22301125Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
- Background: PubMed 25342124Virgili G, Parravano M, Menchini F, Evans JR. Anti-vascular endothelial growth factor for diabetic macular oedema. Cochrane Database Syst Rev. 2014 Oct 24;(10):CD007419. doi: 10.1002/14651858.CD007419.pub4.
- Background: PubMed 18254088Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2.
- Background: PubMed 27164896Goni FJ, Stalmans I, Denis P, Nordmann JP, Taylor S, Diestelhorst M, Figueiredo AR, Garway-Heath DF. Elevated Intraocular Pressure After Intravitreal Steroid Injection in Diabetic Macular Edema: Monitoring and Management. Ophthalmol Ther. 2016 Jun;5(1):47-61. doi: 10.1007/s40123-016-0052-8. Epub 2016 May 10.
- Background: PubMed 27183546Parrish RK 2nd, Campochiaro PA, Pearson PA, Green K, Traverso CE; FAME Study Group. Characterization of Intraocular Pressure Increases and Management Strategies Following Treatment With Fluocinolone Acetonide Intravitreal Implants in the FAME Trials. Ophthalmic Surg Lasers Imaging Retina. 2016 May 1;47(5):426-35. doi: 10.3928/23258160-20160419-05.
- Background: PubMed 13129863Funatsu H, Yamashita H, Ikeda T, Mimura T, Eguchi S, Hori S. Vitreous levels of interleukin-6 and vascular endothelial growth factor are related to diabetic macular edema. Ophthalmology. 2003 Sep;110(9):1690-6. doi: 10.1016/S0161-6420(03)00568-2.
- Background: PubMed 15878060Funatsu H, Yamashita H, Sakata K, Noma H, Mimura T, Suzuki M, Eguchi S, Hori S. Vitreous levels of vascular endothelial growth factor and intercellular adhesion molecule 1 are related to diabetic macular edema. Ophthalmology. 2005 May;112(5):806-16. doi: 10.1016/j.ophtha.2004.11.045.
- Background: PubMed 16120866Aiello LP. Angiogenic pathways in diabetic retinopathy. N Engl J Med. 2005 Aug 25;353(8):839-41. doi: 10.1056/NEJMe058142. No abstract available.
- Background: PubMed 18670086Wang K, Wang Y, Gao L, Li X, Li M, Guo J. Dexamethasone inhibits leukocyte accumulation and vascular permeability in retina of streptozotocin-induced diabetic rats via reducing vascular endothelial growth factor and intercellular adhesion molecule-1 expression. Biol Pharm Bull. 2008 Aug;31(8):1541-6. doi: 10.1248/bpb.31.1541.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Cheong-Leen principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iluvien 0.19 MG Drug Implant and Ranibizumab Injection [Lucentis] in people with Diabetic Macular Edema and Diabetes, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lucentis Injections received in the study eye (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03784443, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.