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Completed

NCT Number: NCT00363714

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)

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.

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Key information

Conditions

Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN211745

Drug

100microgram single intravitreal injection

Other names: Sirna-027

Primary outcomes

  1. Adverse Events

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

Secondary outcomes

  1. 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

  2. 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

  3. OCT

    Time frame: Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84

  4. Fluorescein Angiography (FA)

    Time frame: Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Collaborators

  • Sirna Therapeutics Inc.

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2006
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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