Prophylaxis for Anti-VEGF-induced IOP Elevation

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of our study is to determine the effect of prophylactic treatment with brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL) or placebo therapy (Refresh tears®, Allergan; Dublin, IRL) on long-term IOP measurements in patients receiving serial intravitreal injection of 0.5 mg ranibizumab (0.05 mL) with six months follow-up. Intraocular pressure measurements will be correlated with changes on ancillary testing (Humphrey 24-2 visual field testing and optical coherence tomography (OCT) of the optic nerve head (ONH). Our study would be the first large, prospective, randomized double-blind placebo-controlled trial to examine the relationship between anti-vascular endothelial growth factor (VEGF) therapy and sustained ocular hypertension.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Brimonidine Tartrate; Brimonidine Tartrate, Timolol Maleate Drug Combination; Endothelial Growth Factors

Criteria

Inclusion Criteria:

• Age equal to or greater than 18 years

• Baseline visual acuity between 20/40 and 20/200 in the eye chart score

• Diagnosed with either, CNV secondary to neovascular AMD, CSME secondary to diabetes mellitus (DM), or CSME secondary to retinal vein occlusion (RVO)

Exclusion Criteria:

• Baseline IOP ≥30 mmHg

• Diagnosed with Neovascular glaucoma

• Patients unable to undergo Humphrey 24-2 visual field testing or optical coherence tomography

• Active ocular inflammatory disease including uveitis

• Prior retinal or vitreous surgery including vitrectomy, gas tamponade, silicone oil tamponade or scleral buckling

• Prior surgical management of glaucoma including trabeculectomy or filtering device

• Active hepatitis or clinically significant liver disease

• Clinically significant kidney disease

• History of penetrating injury or severe ocular trauma

• Concurrent enrolment in other clinical trial