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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)

NCT ID: NCT00363714

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration Choroidal Neovascularization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

100microgram single intravitreal injection

2

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

200microgram single intravitreal injection

3

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

400microgram single intravitreal injection

4

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

800microgram single intravitreal injection

5

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

1200microgram single intravitreal injection

6

Single intravitreal injection

Group Type EXPERIMENTAL

AGN211745

Intervention Type DRUG

1600microgram single intravitreal injection

Interventions

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AGN211745

100microgram single intravitreal injection

Intervention Type DRUG

AGN211745

200microgram single intravitreal injection

Intervention Type DRUG

AGN211745

400microgram single intravitreal injection

Intervention Type DRUG

AGN211745

800microgram single intravitreal injection

Intervention Type DRUG

AGN211745

1200microgram single intravitreal injection

Intervention Type DRUG

AGN211745

1600microgram single intravitreal injection

Intervention Type DRUG

Other Intervention Names

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Sirna-027 Sirna-027 Sirna-027 Sirna-027 Sirna-027 Sirna-027

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sirna Therapeutics Inc.

INDUSTRY

Sponsor Role collaborator

Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Baltimore, Maryland, United States

Site Status

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20609706 (View on PubMed)

Other Identifiers

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AGN211745

Identifier Type: -

Identifier Source: secondary_id

SIRNA 0401

Identifier Type: -

Identifier Source: org_study_id

NCT00495742

Identifier Type: -

Identifier Source: nct_alias