None listed
Conditions
Brief summary
Diabetic retinopathy is one of the most debilitating complications of diabetes. Diabetic Macular Oedema (a retinopathy) may be related to a combination of inflammatory and angiogenic cytokines that exist in the blood and aqueous fluid in the eye. The main objective of the study is to assess if aqueous and plasma cytokine concentrations of angiogenic/ inflammatory cytokines correlate with the change in mean best-corrected visual acuity from baseline to 12 months
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.
Only dosing schedule is adjusted on a PRN basis, not the dosing ranges. Dosing ranges will remain the same throughout the study duration.
Dosing schedule is determined by the following:
As per the RESTORE study, all partic
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. Only dosing schedule is adjusted on a PRN basis, not the dosing ranges. Dosing ranges will remain the same throughout the study duration. Dosing schedule is determined by the following: As per the RESTORE study, all participants will undergo three consecutive, monthly injections, followed by an as required dosing schedule (PRN). After month 2 (week 8), at monthly study visits, the need for further intravitreal treatment will be assessed based on BCVA and OCT assessment. Monthly ranibizumab injections would be suspended when: • No (further) BCVA improvement is attributed in the opinion of the investigator to treatment with intravitreal injection at the 2 last consecutive visits, • BCVA letter score >84 (6/6) at the last 2 consecutive follow up visits Monthly ranibizumab injections would be reinitiated when: • Decrease in BCVA due to DME progression in the opinion of the masked study team Monthly ranibizumab will be continued if there is continued BCVA improvement or if in the treating physicians’ opinion, disease stability has not been achieved.
Sponsors
The Centre for Eye Research Australia
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
(i) Age >18 years (ii) 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 (iii) Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120) (iv) Central macular thickness of >300 microns as measured by Heidelberg Optical coherence tomography.
Exclusion criteria
Systemic (v) Uncontrolled blood pressure (>180 mmHg, systolic and 110 mmHg, diastolic) (vi) Chronic renal failure (vii) Major surgery within one month of study (viii) Previous systemic anti-VEGF treatment (ix) Women of childbearing potential not using adequate contraception and women who are breast feeding (x) Intercurrent severe disease such as septicaemia Ocular (i) Glaucoma which is uncontrolled or is controlled but with glaucomatous visual field defects (ii) Past history of severe steroid response with IOP > 35 mmHg following steroid treatment (iii) Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration) (iv) VA of <6/60 in the fellow eye (v) Argon laser photocoagulation within 3 months of study entry (vi) Previous intraocular surgery (within 6 months) (vii) Prior use of intravitreal anti-VEGF agents (within 3 months) or corticosteroids (within 6 months) (viii) Stroke or myocardial infarction less than 3 months prior to screening. (ix) Any active periocular or ocular infection or inflammation at screening or baseline.
Outcome results
None listed