Overview

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

Status:
Unknown status
Trial end date:
2021-05-01
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Sydney
Collaborator:
Center for Eye Research Australia
Treatments:
Aflibercept
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

- 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