A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00363714

Enrollment

Registered

2006-08-15

Start date

2004-11-30

Completion date

2007-04-30

Last updated

2008-08-18

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

Conditions

Age-Related Macular Degeneration, Choroidal Neovascularization

Brief summary

The purpose of this study will be to assess the safety and tolerability and dose-limiting toxicity of a single intravitreal injection of Sirna-027 (AGN211745) and to assess the anatomical changes in the retina, changes in CNV, and changes in visual acuity. Escalation to the next dose cohort will be completed following minimum of 2 weeks follow-up. Patients will be monitored intensively for three months, and then followed-up for safety up to 24 months post-injection.

Interventions

DRUGAGN211745

100microgram single intravitreal injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Active AMD with Subfoveal CNV (classic and/or occult CNV) * CNV lesion thickness \>/= 250um by OCT assessment * Visual acuity in study eye of \</= 20/100 but not worse than 20/800 * Not eligible for or refused standard treatment

Exclusion criteria

* Females of childbearing potential * Other causes of CNV including pathologic myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis * Any intraocular surgery or treatment of AMD with Visudyne within 3 months of study entry * CNV lesion \>/= 12 MPS disc area

Design outcomes

Primary

Measure	Time frame
Adverse Events	Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84

Secondary

Measure	Time frame
Visual Acuity using the Diabetic Retinopathy Study chart	Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
IOP	Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
OCT	Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
Fluorescein Angiography (FA)	Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026