Brinzolamide-brimonidine Fixed Combination for Preventing IOP Elevation After Intravitreal Anti-VEGF Injections

G

General Hospital of Athens Elpis

Status

Completed

Conditions

Intraocular Pressure
Eye Diseases
Injection Complication

Treatments

Drug: Brinzolamide-brimonidine Fixed Combination

Study type

Interventional

Funder types

Other

Identifiers

NCT04523844
1992

Details and patient eligibility

About

This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF). Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.

Full description

The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.

Enrollment

47 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors

Exclusion criteria

  • history of glaucoma or ocular hypertension
  • use of topical medications (e.g. IOP-lowering medication, corticosteroids)
  • pseudoexfoliation
  • pigment dispersion syndrome
  • corneal diseases
  • active intraocular inflammation
  • any intraocular surgery in the last 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

47 participants in 2 patient groups

Brinzolamide-brimonidine fixed combination
Active Comparator group
Description:
One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection
Treatment:
Drug: Brinzolamide-brimonidine Fixed Combination
No topical IOP-lowering medication
No Intervention group
Description:
No IOP-lowering drops are instilled before the intravitreal injections

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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