A phase II, 12 month, randomized, sham-controlled trial of ranibizumab (Lucentis) combined with grid laser compared with laser alone for the treatment of recalcitrant, diabetic macular oedema.

Phase 2

Recruiting

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

• Registration Number: ACTRN12611000063910
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

I.Age 18 years or older.
I.Diabetic macula oedema involving the fovea.
II.OCT central retinal thickness greater than 250 microns or paracentral macular thickness greater than 300um.
III.Best-corrected visual acuity (BCVA) of 0.3 to 1.90 logMAR (6/12-6/477 Snellen equivalent) in the study eye.
IV.At least one full grid or 2 focal laser treatments to DMO no sooner than 4 months prior to randomisation.
V.Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute

Exclusion Criteria

I.Macular ischaemia on Fundus Fluroscein Angiogram(FFA)
II.Untreated retinal or iris neovascularization.
III.Subfoveal fibrosis or atrophy in the study eye.
IV.History of vitrectomy surgery in the study eye.
V.History of idiopathic or autoimmune-associated uveitis in either eye.
VI.Pregnancy, breastfeeding or inadequate birth control in premenopausal females. All patients of child-bearing potential will be required to have a urinary pregnancy test at the screening visit and if sexually active, prior to each intravitreal ranibizumab injection.
VII.Loss of vision due to other causes,
VIII.Intercurrent severe systemic disease.
IX.Any condition affecting follow-up or documentation.
X.Active ocular, periocular or systemic infection.
XI.Idiopathic thrombocytopaenic purpura.
XII.Hypersensitivity to ranibizumab.
XIII.Previous treatment with anti-vascular endothelial growth factor(VEGF) agents within 6 weeks of enrolment.
XIV.Triamcinolone intravitreal or subtenon injection within 4 months prior to randomisation.
XV.Past known history of stroke or myocardial infarction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective: Improve the vision of patients with diabetic macular oedema (DMO) affecting the centre of the fovea that has persisted despite laser treatment.Outcomes will be assessed via Best Corrected Visual Acuity testing(BCVA),Central Retinal Thickness,Intraocular pressure and eye examination from medical officer.[Following first visit at baseline, there are 2 weekly visits until week 10, another visit scheduled for week 14 then 6 weekly visits until the completion and review of DMO for a 12 month period.]

Secondary Outcome Measures

Name	Time	Method
Secondary objective: Reduce retinal thickness as measured by OCT (optical coherence tomography).[OCT will be performed at first visit at baseline, then 2 weekly until week 10, week 14, then 6 weekly until the completion and review of DMO for a 12 month period.]