Intravitreal Tissue Plasminogen Activator (tPA), Perfluoropropane (C3F8), and Ranibizumab for Neovascular Age-Related Macular Degeneration and Submacular Haemorrhage (TAPAS): A Randomized, Double-Masked, Controlled, Factorial, Feasibility Study - TAPAS Study

King's College London0 个研究点目标入组 0 人开始时间: 2013年1月22日最近更新: 2024年9月9日

适应症

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•- SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance;
•- Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye;
•- Diabetic maculopathy in the study eye;
•- Visually significant cataract in the study eye;
•- Amblyopia in the study eye;
•- Presence of other ocular disease causing concurrent vision loss in the study eye;
•- Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8);
•- Pregnant and or lactating women;
•- Women of childbearing potential including those who are not sterilised or at least one year post menopausal;
•- Participation in a clinical trial in the preceding 6 months;
•- Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage;
•- Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to the development of the SMH;
•- Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab, bevacizumab or aflibercept;
•- Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements.
•- Unable to give informed consent

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