Prophylaxis for Anti-VEGF-induced IOP Elevation

NCT02623023 | Withdrawn DMC

• 1 other identifier: PAVE-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• long-term intraocular pressure measurements

  long-term IOP measurements in patients receiving serial IVI of 0.5 mg ranibizumab (0.05 mL) with six months follow-up

  6 months

Study Arms (2)

Combigan group

EXPERIMENTAL

Combigan will be administered twice a day on the day before the intraocular injection and once in the morning of the injection

Drug: Combigan

Refresh tears

PLACEBO COMPARATOR

Refresh tears will be administered twice a day on the day before the intraocular injection and once in the morning of the injection

Other: Refresh tears

Interventions

Combigan DRUG

brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL)

Also known as: (Combigan®

Combigan group

Refresh tears OTHER

This is a placebo group. Refresh tears®, Allergan; Dublin, IRL, is a lubricant eye drop that keeps they eye hydrated

Refresh tears

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Ocular Hypertension

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Timolol; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Brimonidine Tartrate; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: December 7, 2015
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 22, 2023

Record last verified: 2023-05