RecruitingPhase 2ACTRN12611000091909

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.


Sponsor

Royal Adelaide Hospital

Enrollment

40 participants

Start Date

Apr 7, 2010

Study Type

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

Sex: Both males and femalesMin Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Age-related macular degeneration (AMD) is a common eye condition that causes blurry vision or vision loss in the center of your field of view. The "wet" or exudative form of AMD involves abnormal blood vessels growing under the retina and leaking fluid. This study is testing a treatment plan that combines ranibizumab (Lucentis — an injection given into the eye) with regular triamcinolone (a steroid given around the eye) to find out if this combination can maintain or improve vision while reducing the number of injections needed compared to current standard treatments. You may be eligible if: - You are 50 years or older - You have active wet AMD affecting the central area of the retina (the fovea) - The thickness of your retina measured by OCT scan is greater than 300 microns - Your best-corrected vision is between 20/40 and 20/400 - Your kidney function is adequate You may NOT be eligible if: - You have had previous laser treatment directly under the central retina in the study eye - There is scarring or atrophy under the center of the retina - You have had vitrectomy (eye surgery) in the study eye - You are pregnant or of childbearing age and not using contraception - You have uncontrolled glaucoma - You have a known allergy to ranibizumab or triamcinolone - You are known to have a strong response to steroids - You are on high-dose oral steroids (5 mg prednisolone or more daily) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 mont

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)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611000091909