TAPAS Study

• Research type

  Research Study

• Full title

  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

• IRAS ID

  111228

• Contact name

  Timothy Jackson

• Sponsor organisation

  King's Health Partners Clinical Trials Office

• Eudract number

  2012-004078-24

• ISRCTN Number

  vvvvv

• Research summary

  This study investigates the use of tissue plasminogen activator (tPA), a 'clot-buster' drug used to treat stroke, alone and in combination with pfluropropane (C3F8), a gas used commonly in retinal surgery. These agents will be used to treat submacular haemorrage (SMH). SMH is a visually devastating complication of wet age-related macular degeneration (AMD), in which severe bleeding occurs under the macula, the part inside the back of the eye that is packed with the light-sensitive cells that provide fine central vision. Wet AMD is the most common cause of blindness and SMH is one of the most severe subtypes of wet AMD. SMH can occur in up to a fifth of patients with wet AMD. The standard treatment for wet AMD without SMH is Ranibizumab, a drug injected into the eye. There is however no consensus regarding the best treatment of AMD with SMH, as people with SMH were excluded from the major trials of Ranibizumab. There is however emerging evidence that combined eye injections of tPA (to dissolve the SMH clot), C3F8 (to mechanically displace the dissolved blood), and Ranibizumab (to treat the underlying wet AMD) lead to greatly increased vision in people with an otherwise very poor outcome. We will therefore undertake a randomized, double-masked, clinical trial of 55 people with SMH and wet AMD, using these drugs together, and in different combinations, to see which is best. We aim to determine if they produce a visual outcome that is superior to standard care, with a favourable safety profile. We will also measure the size of the blood clot and scarring using computer analysis of macula photographs. If our preliminary study suggests that these drugs are effective, then it will provide the information needed to design a large, definitive trial.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1928

• Date of REC Opinion

  24 Jan 2013

• REC opinion

  Further Information Favourable Opinion