An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

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Allergan

Status and phase

Completed
Phase 2
Phase 1

Conditions

Retinitis Pigmentosa

Treatments

Drug: 200 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
Drug: 100 µg Brimonidine Tartrate Implant
Drug: 400 µg Brimonidine Tartrate Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00661479
190342-028D

Details and patient eligibility

About

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Retinitis Pigmentosa in both eyes
  • Visual acuity between 20/40 to count fingers

Exclusion criteria

  • Growth of new blood vessels in the eye
  • Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
  • Any ocular disease that can interfere with diagnosis and or assessment of disease progression
  • Significant near-sightedness
  • HIV
  • Female patients who are pregnant, nursing, or planning pregnancy

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

21 participants in 4 patient groups

400 µg Brimonidine Tartrate Implant Group B
Experimental group
Description:
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Treatment:
Drug: 400 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
200 µg Brimonidine Tartrate Implant Group B
Experimental group
Description:
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Treatment:
Other: Sham (no implant)
Drug: 200 µg Brimonidine Tartrate Implant
100 µg Brimonidine Tartrate Implant Group B
Experimental group
Description:
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Treatment:
Drug: 100 µg Brimonidine Tartrate Implant
Other: Sham (no implant)
100 µg Brimonidine Tartrate Implant Group A
Experimental group
Description:
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Treatment:
Drug: 100 µg Brimonidine Tartrate Implant
Other: Sham (no implant)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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