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Diabetic RetinopathyPhase 4LADAMONCT02432547

Laser Therapy Combined With Intravitreal Aflibercept vs Intravitreal Aflibercept Monotherapy (LADAMO)

A Phase 4 study testing Aflibercept and Targeted laser therapy in people with Diabetic Retinopathy, run by University of Sydney at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept according to a treat and extend protocol. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Aflibercept and Targeted laser therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesAustralia
Study dates
15 Jun 2017to 24 May 2022
Phase
Phase 4
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

  • At screening, the study eye must have DMO with retinal thickness > 300 microns in central 1mm subfield on Spectral domain OCT
  • Age >= 18 years
  • Diagnosis of diabetes mellitus
  • Best corrected visual acuity of 35-79 LogMAR letters at 4 meters (approximately 6/7.5-6/60) in the study eye
  • Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised
  • Peripheral retinal ischaemia affecting an area greater than 10 disc diameters of the wide-field fundus fluorescein angiogram (as per the Central Vein Occlusion Study)
  • Centre involving DMO, which in the opinion of the investigator, would not benefit from focal macular laser treatment (e.g. diffuse leak from the capillary bed, disruption of the foveal avascular zone or perifoveal capillary dropout, complete macular grid laser).
  • Written informed consent has been obtained

Who cannot join

  • Known allergy to aflibercept or agents used in the study
  • Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception
  • Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) in the study eye.
  • Macular oedema due to other causes in the study eye.
  • Macula hole, vitreo-macular traction or significant epiretinal membrane in the study eye.
  • An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis)
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  • Treatment with intravitreal triamcinolone acetonide (IVTA) within the last 6 months or peribulbar triamcinolone within the last 3 months, or anti-VEGF drugs (bevacizumab, ranibizumab or aflibercept) within the last 2 months in the study eye.
  • Cataract surgery within the last 3 months in the study eye
  • Previous PRP laser treatment in the study eye
  • Previous vitrectomy in study eye
  • Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 12 months
  • Intercurrent severe disease such as septicaemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social)
  • History of chronic renal failure requiring dialysis or renal transplant
  • Blood pressure >180/110
  • Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Centre for Eye Research Australia

    Melbourne, Victoria, 3002

  • Save Sight Institute

    Sydney, New South Wales, 2001

Other trials in Australia

About this study

Official title: A Phase IV Randomised Clinical Trial of Laser Therapy for Peripheral Retinal Ischaemia Combined With Intravitreal Aflibercept (Eylea®) Versus Intravitreal Aflibercept Monotherapy for Diabetic Macular Oedema

This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept according to a treat and extend protocol.

The specific aim of the study is to test whether laser therapy of peripheral retinal ischaemia reduces the overall number of intravitreal aflibercept injections required to control DMO over a 24 month period.

Read the detailed description

Diabetic retinopathy is the most common cause of blindness in individuals between the ages of 20 and 65 years in developed countries. Swelling of the central retina, or "macular oedema", is the commonest cause of visual loss in diabetic retinopathy.

Recent studies have suggested peripheral retinal ischaemia contributes to macula oedema in diabetes and retinal vein occlusions. Intravitreal anti-Vascular Endothelial Growth Factor (VEGF) therapy, such as Aflibercept (Eylea) has shown encouraging results in managing Diabetic Macular Oedema (DMO). There is evidence that regular treatment with anti-VEGF drugs reduces DMO and improves vision on average.

Previous research at this institution has shown that an average of between 7 and 11 injections are required in the first year to stabilise the disease. However, there is a significant burden to patients in terms of frequent visits to the eye specialist, time off work and repeated injections into the eye. The purpose of this study is to see whether targeted peripheral retinal laser therapy to areas of the retina with impaired blood supply can reduce the number of intravitreal aflibercept injections required over 2 years to stabilise DMO.

Being tested
Aflibercept, Targeted laser therapy
Keywords
Diabetic, Macular Oedema, Retinopathy
Medical subject headings
Diabetic Retinopathy, Macular Edema, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfliberceptDrug

    Also called Eylea

    Aflibercept is a soluble decoy receptor and is produced by fusing all-human DNA sequences of the second immunoglobulin (Ig) domain of human VEGF receptor (VEGFR) 1 to the third Ig domain of human VEGFR-2, which are then fused to the Fc region of human IgG-1. By binding to VEGF-A, aflibercept prevents activation of the native VEGF receptors, VEGFR-1 and VEGFR-2. The study sites will be supplied by Bayer with aflibercept. Intravitreal injection of 2mg in 0.05 ml aflibercept will be administered to the study eye, according to a pre-defined treat and extend regimen.

  • Targeted laser therapyProcedure or surgery

    Also called Laser

    In the experimental group, targeted laser photocoagulation will be applied to areas of peripheral retinal ischaemia 1 month after the initial intravitreal aflibercept. The trial design allows another session of targeted laser photocoagulation 1 month later to complete the treatment if required. Wide-field photography is planned at 3 months to determine if further targeted laser photocoagulation is required, and if so a third session can be applied. The laser settings are based on those used in current clinical practice and have been prospectively defined in the protocol.

Study groups in NCT02432547
Study groupRoleWhat they receive
Aflibercept MonotherapyActive comparatorIntravitreal aflibercept injections according to a treat and extend regimen.
Receives: Drug: Aflibercept
Targeted laser therapy with AfliberceptExperimentalTargeted laser photocoagulation therapy to areas of peripheral retinal ischaemia and intravitreal aflibercept injections using a treat and extend regimen.
Receives: Drug: Aflibercept; Procedure: Targeted laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of intravitreal aflibercept injections over 24 months

    Number of intravitreal aflibercept injections in each of the 2 groups required over 24 months

    Measured: 24 months

Secondary outcomes (19)

  1. Number of intravitreal aflibercept injections over 12 months

    Number of intravitreal aflibercept injections in each of the 2 groups required over 12 months

    Measured: 12 months

  2. Proportion of eyes that have central macular thickness <300 microns at 12 months

    Measured: 12 months

  3. Mean change in central macular thickness (CMT) as measured by OCT at 12 months

    Measured: 12 months

  4. Mean change in best corrected visual acuity

    Mean change in best corrected visual acuity at 12 months

    Measured: 12 months

  5. Any change in best corrected visual acuity at 12 months

    Any change in best corrected visual acuity at 12 months

    Measured: 12 months

  6. Effect of peripheral retinal ischaemia on number of aflibercept injections

    Correlation between area of peripheral retinal ischaemia and number of intravitreal injections required at 12 months

    Measured: 12 months

  7. Disc vessel measurement

    Change in disc vessel diameter at 12 months

    Measured: 12 months

  8. Number of intravitreal aflibercept injections in each of the 2 groups required over 24 months

    Measured: 24 months

  9. Proportion of eyes that have central macular thickness <300 microns at 24 months

    Measured: 24 months

  10. Mean change in central macular thickness (CMT) as measured by OCT at 24 months

    Measured: 24 months

  11. Mean change in best corrected visual acuity

    Mean change in best corrected visual acuity at 24 months

    Measured: 24 months

  12. Any change in best corrected visual acuity at 24 months

    Any change in best corrected visual acuity at 24 months

    Measured: 24 months

  13. Effect of peripheral retinal ischaemia on number of aflibercept injections

    Correlation between area of peripheral retinal ischaemia and number of intravitreal injections required at 24 months

    Measured: 24 months

  14. Disc vessel measurement

    Change in disc vessel diameter at 24 months

    Measured: 24 months

  15. Time until vision stabilisation

    Length of time from baseline to vision stabilisation

    Measured: 24 months

  16. Quality of life assessment

    Quality of life assessment using IVI and NEI VFQ-25 forms at 24 months

    Measured: 24 months

  17. Change in area of macular hard exudates

    Change in area of macular hard exudates from baseline to 24 months

    Measured: 24 months

  18. Change in distance of closest hard exudate from the foveal centre

    Change in distance of closest hard exudate from the foveal centre between baseline and 24 months

    Measured: 24 months

  19. Mean change in treatment interval over time

    Mean change in treatment interval between intravitreal aflibercept injections over time

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2015 (estimated)
  2. Study start15 Jun 2017
  3. Primary completion24 May 2022
  4. Study completion24 May 2022

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432547
Sponsor's protocol ID
X14-0157
Acronym
LADAMO
Status last verified
May 2022
First submitted
23 Apr 2015
Last updated
31 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept and Targeted laser therapy in people with Diabetic Retinopathy, run by University of Sydney at 2 sites in Australia.

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 8 inclusion and 15 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: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 intravitreal aflibercept injections over 24 months (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 NCT02432547.

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 31 May 2022.

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