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An Open-Label, Dose Escalation Study of the Safety and Tolerability of 20089 (Triamcinolone Acetonide Intravitreal Injection) in the Treatment of Patients with Cystoid Macular Edema Associated with Retinal Vein Occlusion or Cataract Surgery

An Open-Label, Dose Escalation Study of the Safety and Tolerability of 20089 (Triamcinolone Acetonide Intravitreal Injection) in the Treatment of Patients with Cystoid Macular Edema Associated with Retinal Vein Occlusion or Cataract Surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000603314
Enrollment
10
Registered
2008-12-03
Start date
2007-05-11
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The purpose of this study is to test the safety and tolerability of a extended duration drug delivery system for the eye.

Interventions

Intravitreal injection of extended release triamcinolone acetonide for treatment of macular edema. Each patient will receive only one injection. The first cohort of five patients will all receive the 6.9 mg injection. The second cohort of five patients will receive the 13.8 mg injection.

Sponsors

Icon Bioscience
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cystoid Macular Edema associated with retinal vein occlusion or post cataract surgery

Exclusion criteria

Visual acuity not likely to be improved by treatment; recent treatment by other intravitreal therapies or laser therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026