RecruitingPhase 2ACTRN12611000063910

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.

The effect of Ranibizumab (Lucentis) combined with grid laser compared with laser alone on vision in patients with recalcitrant, diabetic macular oedema

Sponsor

Novartis

Enrollment

40 participants

Start Date

Apr 8, 2010

Study Type

Interventional

Conditions

Diabetic Retinopathy Diabetic Macular Oedema

Summary

Objectives: Primary objective: Improve the vision of patients with diabetic macular oedema (DMO) affecting the centre of the fovea that has persisted despite laser treatment. Secondary objective: Reduce retinal thickness as measured by OCT (optical coherence tomography). Strategic goal: Primary Objective: 1. To determine if combined treatment with ranibizumab and grid laser for recalcitrant diabetic maculopathy is more effective in improving visual acuity than grid laser alone. Secondary Objectives: 1. To design a treatment protocol that requires less visits and intravitreal injections than similar studies currently in progress. This would be more acceptable to patients and clinicians.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

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 Criteria15

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.

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Interventions

Ranibizumab (Lucentis) combined with grid laser compared with laser alone for the treatment of recalcitrant, diabetic macular oedema. Ranibizumab(Lucentis)will be administered via intravitreal in

Ranibizumab (Lucentis) combined with grid laser compared with laser alone for the treatment of recalcitrant, diabetic macular oedema. Ranibizumab(Lucentis)will be administered via intravitreal injection on at least 3 occasions. There will possibly be as many as 9 injections in a 12 month period. Injection dose is 0.05 ml/1.25 mg once/day.The initial 3 injections will be given at 1 month intervals and subsequent injections will be given at the discretion of the attending medical officer at 6 week intervals.The injection procedure will take approximately 5 minutes.