Intra vitreal Lucentis anaesthetic trial

• Research type

  Research Study

• Full title

  A study to assess the equivalence in efficacy of anesthesia using topical Proxymetacaine 0.5% drops versus sub-conjunctival Lignocaine 2% (without adrenaline) for subsequent Intravitreal Injections of Ranibizumab (Lucentis): A Randomized Clinical Trial.

• IRAS ID

  26810

• Contact name

  vasant raman

• Sponsor organisation

  Plymouth Hospitals NHS Trust

• Eudract number

  2010-022644-21

• ISRCTN Number

  Unknown

• Research summary

  Neovascular (wet) age-related macular degeneration causes vision loss due to abnormal blood vessel growth in the retina. The drug ranibizumab can cause regression of the abnormal blood vessels and improvement of vision when injected directly into the vitreous humor of the eye, and is now widely-used as a first line treatment modality. All patients require a course of at least three injections initially. Further injections are required if there is recurrence of the growth of blood vessels. This is monitored by a retinal scan performed at monthly intervals and reinjections are performed based on the results of the retinal scan. As the injections are painful, they are administered after anaesthetizing the surface of the eye (conjunctiva)with either anaesthetic eye drops or a subconjunctival injection of local anaesthetic. Currently there are no recommendations regarding the method of anaesthesia to be used for administering the intravitreal drug. We therefore propose a randomised controlled trial comparing topical proxymetacaine 0.5% (eye drops) versus subconjunctival lidoocaine 2% (without adrenaline)injection with proxymetacaine% as anaesthesia for intravitreal injection of ranimizumab.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  10/H0206/61

• Date of REC Opinion

  4 Jan 2011

• REC opinion

  Further Information Favourable Opinion