None listed
Conditions
Brief summary
We hypothesize that the underlying pathogenesis of Diabetic Macular Oedema (DMO) may be related to a combination of inflammatory and angiogenic cytokines. Although anti-VEGF agents are commonly used for the treatment of DMO, either as a primary measure or more usually in refractory cases, the response to treatment is unpredictable. We propose that measurement of known diabetes association cytokines may allow accurate prediction of response to anti-VEGF treatment and allow a more individualised treatment strategy for patients.
Interventions
All eligible participants will receive treatment with ranibizumab 0.5mg in 50 microliters for intravitreal injection.
All participants will undergo three consecutive, monthly injections, followed by an as required dosing schedule (PRN) for the 12 month duration of the trial.
Sponsors
The Centre for Eye Research Australia (The University of Melbourne)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Age >18 years -Centre-involving diabetic macular oedema that in the opinion of the investigator, would not benefit from macular laser treatment (eg diffuse leak from the capillary bed, disruption of the foveal avascular zone or perifoveal capillary dropout) as determined by fluorescein angiography -Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120) -Central macular thickness of >300 microns as measured by Heidelberg Optical coherence tomography.
Exclusion criteria
Systemic -Uncontrolled blood pressure (>180 mmHg, systolic and 110 mmHg, diastolic) -Chronic renal failure -Major surgery within one month of study -Previous systemic anti-VEGF treatment -Women of childbearing potential not using adequate contraception and women who are breast feeding -Intercurrent severe disease such as septicaemia Ocular -Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects -Past history of severe steroid response with IOP > 35 mmHg following steroid treatment -Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration) -VA of <6/60 in the fellow eye -Argon laser photocoagulation within 3 months of study entry -Previous intraocular surgery (within 6 months) -Prior use of intravitreal anti-VEGF agents (within 3 months) or corticosteroids (within 6 months) -Stroke or myocardial infarction less than 3 months prior to screening. -Any active periocular or ocular infection or inflammation at screening or baseline.
Outcome results
None listed