NCT00363714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2004

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 18, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

August 10, 2006

Last Update Submit

August 14, 2008

Conditions

Age-Related Macular DegenerationChoroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

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

Secondary Outcomes (4)

  • 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)

Study Arms (6)

1

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

2

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

3

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

4

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

5

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

6

EXPERIMENTAL

Single intravitreal injection

Drug: AGN211745

Interventions

AGN211745DRUG

100microgram single intravitreal injection

Also known as: Sirna-027
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Related Publications (1)

  • Kaiser PK, Symons RC, Shah SM, Quinlan EJ, Tabandeh H, Do DV, Reisen G, Lockridge JA, Short B, Guerciolini R, Nguyen QD; Sirna-027 Study Investigators. RNAi-based treatment for neovascular age-related macular degeneration by Sirna-027. Am J Ophthalmol. 2010 Jul;150(1):33-39.e2. doi: 10.1016/j.ajo.2010.02.006.

    PMID: 20609706DERIVED

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

November 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 18, 2008

Record last verified: 2008-08

Locations

US(2)