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).
- Conditions
- exudative age related macular degenerationEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12611000091909
- Lead Sponsor
- Royal Adelaide Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One primary outcome measures are visual acuity at 12 months assessed by using Log Mar for best corrected visual accuity[Initial baseline measurement followed by monthly follow up assessments for a twelve month period in total.];number of intravitreal injections required assessed in medical records and trial source notes[Monthly follow up for a twelve month period in total.]
- Secondary Outcome Measures
Name Time Method il[Nil]