A phase 2, twelve month, randomized, controlled trial of combined treatment for exudative age related macular degeneration with variable dosing Ranibizumab (Lucentis) and Sub-Tenon Triamcinolone (Kenacort-A 40).
The effect of variable dosing Ranibizumab (Lucentis) and Sub-Tenon Triamcinolone (Kenacort-A 40) on visual acuity and number of intravitreal injections in patients with exudative age related macular degeneration.
Royal Adelaide Hospital
40 participants
Apr 7, 2010
Interventional
Conditions
Summary
The purpose of this study is to evaluate a treatment regimen of variable-dosing ranibizumab and regular subtenons triamcinalone (STTA) for exudative age related macular degeneration. Our aim is to reduce the number of intravitreal injections required with the same or better visual outcome as currently accepted treatment regimens.
Eligibility
Inclusion Criteria6
- Age 50 years or older.
- Active primary or recurrent subfoveal choroidal neovascularization secondary to Age Related Macular Degeneration (ARMD).
- Occular Coherence Tomography(OCT) central retinal thickness greater than 300 microns.
- Best-corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent) in the study eye.
- Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
- In patients with bilateral presentation of exudative ARMD the eye of most recent onset will be enrolled.
Exclusion Criteria17
- Previous subfoveal focal laser photocoagulation in the study eye.
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding day 0 (day of first injection).
- Subfoveal fibrosis or atrophy in the study eye.
- History of vitrectomy surgery in the study eye.
- Aphakia or absence of the posterior capsule in the study eye.
- History of idiopathic or autoimmune-associated uveitis (intraocular inflammation) in either eye.
- Pregnancy. Sexually active pre-menopausal women will be required to have a serum Beta-Human chorionic gonadotropin (Beta-HCG) pregnancy test prior to each injection.
- Uncontrolled glaucoma (defined as intraocular pressure >25 mmHg despite treatment with antiglaucoma medication).
- Loss of vision due to other causes,
- Systemic treatment with greater than or equal to 5 mg prednisolone (or equivalent) daily.
- Intercurrent severe systemic disease.
- Any condition affecting follow-up or documentation.
- Active ocular, periocular or systemic infection.
- Idiopathic thrombocytopaenic purpura.
- Hypersensitivity to either Ranibizumab or Triamcinalone.
- Known severe steroid responder.
- Presence of a scleral buckle from previous retinal detachment surgery
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Interventions
treatment regimen of variable-dosing ranibizumab and regular subtenons triamcinalone (STTA) The treatment adminstered is Ranibizumab (Lucentis) intravitreal injection, 0.5 mg/0.5 ml administered monthly for 3 months then monthly as required judged by the medical officer for up to 12 months. Subtenons Triamcinalone injection(Kenacort-A 40) 40 mg/1 ml will be administered immediately after the first dose of Ranibizumab,then not more than 4 monthly as required there after, for up to 12 months as judged by the medical officer.
Locations(1)
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ACTRN12611000091909