The Influence of Serum and Aqueous Cytokine Concentrations on the Efficacy of Intravitreal Ranibizumab for the Treatment of Diabetic Macular Oedema

Phase 4

• Conditions: Diabetic Macular Oedema; Eye - Diseases / disorders of the eye; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618000079246
• Lead Sponsor: The Centre for Eye Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-19
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess if aqueous and serum cytokine concentrations of angiogenic/ inflammatory cytokines including IL-10 and IL-17 correlate with the change in mean best-corrected visual acuity from baseline to 12 months. <br>Best-corrected visual acuity will be assessed on a LogMAR chart.[12 months after first ranibizumab injection or the baseline visit.]