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)

August 14, 2008 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States
    • Ohio
      • Cleveland, Ohio, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027
EXPERIMENTAL: 2
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027
EXPERIMENTAL: 3
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027
EXPERIMENTAL: 4
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027
EXPERIMENTAL: 5
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027
EXPERIMENTAL: 6
Single intravitreal injection
Drug: AGN211745
100microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
400microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
800microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1200microgram single intravitreal injection
Other Names:
  • Sirna-027
Drug: AGN211745
1600microgram single intravitreal injection
Other Names:
  • Sirna-027

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity using the Diabetic Retinopathy Study chart
Time Frame: 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
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: 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
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: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
Fluorescein Angiography (FA)
Time Frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)
Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Collaborators

Sirna Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIRNA 0401
  • AGN211745

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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