PBA (Ammonaps) in the prevention of intraocular pressure rise caused by corticosteroid eye drops

PBA (4-phenylbutyrate) in the prevention of intraocular pressure increase caused by glucocorticoids - PBA in glucocorticoid glaucoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000225-36-FI

Enrollment

Registered

2015-01-20

Start date

2015-05-20

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular pressure increase caused by glucocorticoid use in genetically predisposed patients

Interventions

Trade Name: Ammonaps tablets 500 mg Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with glucocorticoid caused raise in intraocular pressure encountered in clinical work at Helsinki University Hospital Uveitis dpt Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age (65 years), gravid and nursing mothers

Design outcomes

Primary

Measure	Time frame
Main Objective: Prevention of intraocular pressure raise (group 1+3), decrease in intraocular pressure (group 2);Secondary Objective: No applicable;Primary end point(s): Group 1+3: Patients receive similar glucocorticoid treatment in phase 2 as they do in phase 1. In phase one duration and magnitude of treatment is determined individually based on tendency for IOP rise Group 2: prevention of glaucoma operation and management of uveitis with other, more slow-acting medication;Timepoint(s) of evaluation of this end point: In phase 2 patients receive glucocorticoid medication with same duration as in phase 1 (individually determined)	—

Measure

Time frame

Main Objective: Prevention of intraocular pressure raise (group 1+3), decrease in intraocular pressure (group 2);Secondary Objective: No applicable;Primary end point(s): Group 1+3: Patients receive similar glucocorticoid treatment in phase 2 as they do in phase 1. In phase one duration and magnitude of treatment is determined individually based on tendency for IOP rise Group 2: prevention of glaucoma operation and management of uveitis with other, more slow-acting medication;Timepoint(s) of evaluation of this end point: In phase 2 patients receive glucocorticoid medication with same duration as in phase 1 (individually determined)

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: No other end points	—

Countries

Finland

Contacts

Public ContactHYKS Silmäklinikka

Helsinki University Hospital / dpf of Ophthalmology

heikki.saaren-seppala@hus.fi+35894711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026