The Protocol

Official Trial title: European Consortium for the Study of a Topical Treatment of Neovascular Glaucoma – the STRONG Study

Study design: Prospective, randomized, placebo-controlled, double-masked, three-armed multi-centre trial

Indication: Patients after ischaemic central retinal vein occlusion with a high risk to develop neovascular glaucoma

Treatment: Test product: topical Aganirsen; Reference therapy: placebo

Primary Objective: To avert or minimize the rise in intraocular pressure (IOP) in patients with ischaemic Central Retinal Vein Occlusion (iCRVO) by averting abnormal neovessels formation and further obstruction of the trabecular meshwork by the treatment with Aganirsen.

Secondary Objectives

  • Evaluate efficacy of two Aganirsen doses
  • Assess Aganirsen efficacy relative to placebo on time to and intensity of additional interventions such as PRP or cryotherapy
  • Compare Aganirsen and placebo on health outcome and quality of life (QoL)
  • Confirm positive safety profile of Aganirsen

strong study 1

Eligibility (In- and Exclusion Criteria):

Main Inclusion Criteria:

Subjects meeting all of the following criteria at screening visit and baseline visit will be considered for admission to the trial:

  • Primary ischaemic CRVO or conversion to ischaemic CRVO for no longer than 4 weeks in the study eye
  • BCVA is worse than 20/200 (Snellen equivalent) in the study eye
  • ≥ 10-disc area of retinal capillary obliteration on fluorescein fundus angiography in the study eye
  • IOP in the study eye ≤ 21 mmHg
  • Male or female adults ≥ 18 years

Additionally at least 4 out of 6 criteria have to be fulfilled:

  1. A relative afferent pupillary defect (with a normal fellow eye)
  2. ≥ 10 Cotton-wool spots in the study eye
  3. Venous tortuosity in the study eye
  4. Peripheral visual field defects corresponding to ischaemia: dense scotomas in areas of capillary nonperfusion in the study eye.
  5. Engorged vessels on iris and/or chamber angle in the study eye
  6. Detectable anterior chamber flare in the study eye

Main Exclusion Criteria:

Subjects presenting with any of the following criteria at screening visit and/or baseline visit will not be included in the trial:

  1. Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
  2. Primary or secondary glaucoma in the study eye
  3. Ocular anti-VEGF treatment:
    • Any anti-VEGF ranibizumab or bevacizumab treatment in the study eye in the last 45 days before screening visit
    • Any anti-VEGF aflibercept in the study eye in the last 90 days before screening visit
    • Anti-VEGF in the fellow eye during the trial
  4. Any prior or concomitant use of systemic anti-VEGF products

Find out more here: https://eudract.ema.europa.eu/index.html