ATHENA Study

• Research type

  Research Study

• Full title

  A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension

• IRAS ID

  209972

• Contact name

  Rupert Bourne

• Contact email

  Rupert.Bourne@addenbrookes.nhs.uk

• Sponsor organisation

  AbbVie Deutschland GmBH & Co. KG.

• Eudract number

  2015-002131-18

• Clinicaltrials.gov Identifier

  NCT02507687

• Clinicaltrials.gov Identifier

  Not applicable, Not applicable

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Glaucoma is a condition which can affect sight, usually due to build-up of pressure within the eye (high intraocular pressure (IOP)). Glaucoma can be treated with eye drops, laser treatment or surgery, each of which has its own risk. Patient non- compliance using eye drops can be a problem treating high IOP

  The Bimatoprost SR (sustained release) formulation is very small biodegradable, preservative free implant preloaded into a single use applicator which does not require patient self-administration. Bimatoprost is the same active ingredient as the commercially approved LUMIGAN® eye drops.

  Bimatoprost SR is placed inside the eye between the cornea and the iris. Once placed, the drug is slowly released for about 3 to 4 months and the implant slowly dissolves in about 12 to 15 months.

  This study investigates the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

  The eye with the higher IOP at Baseline will be assigned to be the primary eye. The primary eye will be randomised using a 1:1 ratio to receive either:

  1)SLT administration
  2)Bimatoprost SR

  Study duration is 14 months, including screening period of up to 28 days before washout, washout period of up to 42 days before initial study treatment, plus 52 weeks of follow-up after initial Bimatoprost SR and SLT administration.
  Patients will receive a 360° administration of SLT in 1 eye on Day 1 and an administration of Bimatoprost SR in the contralateral eye on Day 4, with repeat administrations of Bimatoprost SR at Weeks 16 and 32. In order to mask the patient to the treatment assigned to each eye, on Day 1, a sham SLT procedure will be performed in the eye that will receive Bimatoprost SR administrations and a sham administration of Bimatoprost SR, which involves the use of a needleless applicator to touch the eye at the area of insertion for the SLT treated eye

  Patients who complete all study treatments will have a minimum of 22 visits and 7 phone calls

  Approximately 160 participants will take part in this study worldwide

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  16/EE/0421

• Date of REC Opinion

  21 Dec 2016

• REC opinion

  Further Information Favourable Opinion