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A Comparison of Standard Laser With Micropulse Laser for the Treatment of Diabetic Macular Oedema. (DIAMONDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690050
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
Northern Ireland Clinical Trials Unit
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Brief Summary:
DIAMONDS is a Randomised Controlled Clinical Trial that is being carried out in the UK to determine the clinical effectiveness and cost-effectiveness of micropulse laser, compared with standard laser, for the treatment of diabetic macular oedema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Procedure: Diode 577 nm subthreshold micropulse laser Procedure: Standard threshold laser (532 nm laser) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:

Ophthalmologists undertaking laser treatments for DMO at each of the participating centres will also deliver the treatment for the trial. Although, for obvious reasons, ophthalmologists delivering the treatment will not be masked with regards to the laser used, every effort will be made to ensure that participants and outcome assessors (e.g. optometrists measuring visual function, photographers/technicians/nurses obtaining OCT images and ophthalmic technicians obtaining visual fields) will be masked to the allocated treatment. Patients will not be informed before, during, and after the laser treatment about which technology of laser was used for their treatment.

Similarly, the investigators obtaining outcome measures will only have access to the CRF booklet (but not to the notes of the patients) which will contain no information with regards to the type of laser the patient had been allocated or received

Primary Purpose: Treatment
Official Title: Diabetic Macular Oedema and Diode Subthreshold Micropulse Laser (DIAMONDS): A Pragmatic, Multicentre, Allocation Concealed, Prospective, Randomised, Non-inferiority Double-masked Trial
Actual Study Start Date : November 1, 2014
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Diode Subthreshold Micropulse Laser
DSML is a relatively new laser technology aimed at minimising damage ("tissue-sparing") to choroid and retina but maintaining treatment efficacy by its selective effect on the retinal pigment epithelium (RPE). It is performed using laser that, instead of delivering a continuous-wave laser beam, as the standard laser, it provides very small, repetitive, low energy pulses of laser separated by a brief rest period. This rest period allows the tissue to cool down between laser pulses avoiding the increased tissue heat that would be produced by continuous laser and allowing the use of lower laser energy power to achieve an effect. The reduced heat produced in the tissue and the reduced energy power required for the treatment may reduce side effects.
Procedure: Diode 577 nm subthreshold micropulse laser
On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The DSML surgery will be performed by an Ophthamologist

Active Comparator: Standard threshold laser (532 nm laser)
Green-yellow argon laser photocoagulation at threshold levels has been used for many years as the standard laser for the treatment of many retinal disorders including DMO. The ETDRS demonstrated the efficacy of laser in preventing visual loss in patients with DMO.
Procedure: Standard threshold laser (532 nm laser)
On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The standard laser surgery will be performed by an Ophthamologist




Primary Outcome Measures :
  1. Mean change in BCdVA in the study eye at 24 months [ Time Frame: 4, 8, 12, 16, 20 and 24 months ]
    BCdVA in the study eye is assessed by a BCdVA test (using ETDRS visual acuity charts at 4 meters) at baseline and months 4,8,12,16,20 and 24.


Secondary Outcome Measures :
  1. Mean change in binocular BCdVA from baseline to month 24 [ Time Frame: 12 and 24 months ]
    Binocular BCdVA is assessed by a binocular BCdVA test (using ETDRS visual acuity charts at 4 meters) at baseline and at 12 and 24 months

  2. Mean change in central subfield retinal thickness in the study eye [ Time Frame: 24 months ]
    Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT), from baseline to month 24

  3. Mean change in the mean deviation (MD) of the Humphrey 10-2 visual field in the study eye from baseline to month 24 [ Time Frame: 12 and 24 Months ]
    Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 12 and 24 months

  4. Change in the percentage (%) of people meeting driving standards from baseline to month 24 [ Time Frame: 24 months ]
    Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and 24 months

  5. Mean change in EQ-5D 5L from baseline to month 24. [ Time Frame: 24 months ]
    General health (EQ-5D-5L) is measured using EQ-5D 5L questionnaire scores at baseline and 24 months

  6. Mean change in NEI VFQ25 scores from baseline to month 24. [ Time Frame: 24 months ]
    Visual functioning (NEI VFQ-25) is measured using NEI VFQ25 questionnaire scores at baseline and 24 months

  7. Mean change in VisQoL scores from baseline to month 24. [ Time Frame: 24 months ]
    Quality of life (VisQol) is measured using a VisQoL questionnaire scores at baseline and 24 months

  8. Incremental cost per QALY gained [ Time Frame: 24 months ]
    Incremental cost per quality-adjusted life year (QALY) gained is assessed by a Markov model based cost-utility analysis which will extend beyond the trial analysis period to estimate the longer-term cost-effectiveness, with costs and benefits discounted at 3.5%. The model will be populated by data from the trial and supplemented by estimates of effectiveness, quality of life and costs from published literature and expert opinion

  9. Side effects [ Time Frame: 4, 8, 12, 16, 20 and 24 months ]
    Side effects are measured by a review of the participant's medical and ophthalmic history at 4, 8, 12, 16, 20, 24 months

  10. Number of laser treatments needed [ Time Frame: 4, 8, 12, 16, 20 and 24 months ]
    Number of laser treatments needed is assessed by the treating ophthalmologist at 4, 8, 12, 16, 20, 24 months

  11. Use of additional treatments (other than laser) [ Time Frame: 4, 8, 12, 16, 20 and 24 months ]
    Use of additional treatments (other than laser) is assessed by the treating ophthalmologist at 4, 8, 12, 16, 20, 24 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:

  1. Central retinal subfield thickness of > 300 but < 400 microns as determined by SD-OCT due to diabetic macular oedema OR
  2. Central retinal subfield thickness of < 300 microns provided that intraretinal and/or subretinal fluid is present in the central subfield (central 1 mm) related to diabetic macular oedema AND
  3. Visual acuity of > 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent > 20/320)
  4. Amenable to laser treatment, as judged by the treating ophthalmologist
  5. Over 18 years of age

Exclusion Criteria:

Eyes of patients will not be included in the study if:

  1. The macular oedema is due to causes other than diabetic macular oedema such as epiretinal membrane, vitreomacular traction, vein occlusion, or others
  2. The eye is ineligible for macular laser treatment, as judged by the treating ophthalmologist
  3. The eye has DMO and central subfield retinal thickness (CST) of > 400 microns. Doc No: TM09-LB01 Protocol Version 3.0 Final_ 09/01/17 Page 16 of 34
  4. The eye has activeA proliferative diabetic retinopathy (PDR) requiring treatment.
  5. The eye has received intravitreal Anti- Vascular Endothelical Growth Factor (Anti-VEGF) therapy within the previous two months.
  6. The eye has received macular laser treatment within the previous 12 months.
  7. The eye has received intravitreal injection of steroids.
  8. The eye has received cataract surgery within the previous six weeks
  9. The eye has received panretinal photocoagulation within the previous 3 months The patient is
  10. Patients on pioglitazone and the drug cannot be stopped 3 months prior to entering into the trial and for the duration of the study
  11. The patient has chronic renal failure requiring dialysis or kidney transplant
  12. The patient has any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study)
  13. The patient has very poor glycemic control and started intensive therapy within the previous 3 months
  14. The patient will use an investigational drug during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690050


Contacts
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Contact: Noemi Lois, MD, PhD 02890976462 n.lois@qub.ac.uk
Contact: Catherine Adams 02890 639574 CatherineX.Adams@nictu.hscni.net

Locations
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United Kingdom
Belfast Health & Social Care Trust Recruiting
Belfast, United Kingdom
Contact: Noemi Lois, MD, PHD    02890976462    noemi.lois@qub.ac.uk   
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom
Contact: Faruque Ghanchi       Faruque.Ghanchi@bthft.nhs.uk   
Bristol Eye Hospital Recruiting
Bristol, United Kingdom
Contact: Clare Bailey, MD FRCOphth    01173424771    Clare.bailey@bristol.ac.uk   
Frimley Park Hospital Recruiting
Frimley, United Kingdom
Contact: Geeta Menon, FRCS (Ophth)    01276 526982    Geeta.Menon@fhft.nhs.uk   
Hull and East Yorkshire Hospital Recruiting
Hull, United Kingdom
Contact: Louise Downey       Louise.Downey@hey.nhs.uk   
Hinchingbrooke Hospital Not yet recruiting
Huntingdon, United Kingdom
Contact: Marianne Shiew, FRCSEd    01480 416416    marianne.shiew@nhs.net   
King's College Hospital Recruiting
London, United Kingdom
Contact: Haralabos Eleftheriadis    0203 299 9000    h.eleftheriadis@nhs.net   
Moorefields Eye Hospital Recruiting
London, United Kingdom
Contact: Robin Hamilton, CCT    020 7253 3411    robin.hamilton@moorfields.nhs.uk   
Manchester Eye Hospital Recruiting
Manchester, United Kingdom
Contact: Tariq Aslam, FRCSEd    0161 2761234    tariq.aslam@cmft.nhs.uk   
James Cook University Hospital South Tees Recruiting
Middlesborough, United Kingdom
Contact: Ahmed Saad       ahmed.saad@nhs.net   
Newcastle Eye Hospital Recruiting
Newcastle, United Kingdom
Contact: James Talks, FRCO    0191 2825444    james.talks@nuth.nhs.uk   
Oxford John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Samia Fatum, MD    01865 231122    Samia.Fatum@ouh.nhs.uk   
Sheffield Eye Hospital Recruiting
Sheffield, United Kingdom
Contact: Nachiketa Acharya, FRCS    01142261469    Nachiketa.Acharya@sth.nhs.uk   
City Hopsitals Sunderland Recruiting
Sunderland, United Kingdom
Contact: David Steel Steel, FRCOphth    0191 5699039    david.steel@newcastle.ac.uk   
Sponsors and Collaborators
Belfast Health and Social Care Trust
Northern Ireland Clinical Trials Unit
Investigators
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Principal Investigator: Noemi Lois, MD, PhD Queen's University, Belfast
Publications:
[2] NICE guidance. Ranibizumab for treating diabetic macular oedema. TA 237 (STA), superseded by TA 274 (rapid review). ERG Reports

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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03690050    
Other Study ID Numbers: 16028NL-AS
2016-003804-29 ( EudraCT Number )
ISRCTN17742985 ( Registry Identifier: ISRCTN )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belfast Health and Social Care Trust:
Diabetic macular oedema
Diabetic retinopathy
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases