drugset / Trial / NCT01835067

Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD

NCT01835067

Phase 2/3 Completed 55 enrolled King's College Hospital NHS Trust
RandomizedSingle-groupDouble-blindTreatment

Summary

This study will recruit patients who have recently had a submacular haemorrhage (bleed under the part of the retina responsible for detailed vision), as a complication of wet age-related macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels form under the retina and leak, causing a significant reduction in vision. The study will investigate treatment of the bleed with various combinations of the two drugs: tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke. C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four groups: control group that receive none of the above drugs; one group that receives only tPA; one group that receives only C3F8; and one group that receives both. All patients will receive the current gold standard treatment for wet AMD, ranibizumab (Lucentis®). The aim of the study is to improve vision in a condition, which left untreated, would cause severe visual loss.

Timeline

Start
2014-09
Primary completion
2019-11
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject C3F8 Other / unclassified 0.3 ml Intravitreal
Subject tPA Unknown 50 ug Intravitreal
Background Ranibizumab Monoclonal antibody 500 ug Intravitreal