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)

Age-Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363714
• Other study ID #: SIRNA 0401
• Secondary ID: AGN211745
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 10, 2006
• Last updated: August 14, 2008
• Start date: November 2004
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00495742

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• AGN211745
100microgram single intravitreal injection
• AGN211745
200microgram single intravitreal injection
• AGN211745
400microgram single intravitreal injection
• AGN211745
800microgram single intravitreal injection
• AGN211745
1200microgram single intravitreal injection
• AGN211745
1600microgram single intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Allergan	Sirna Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84	No
Secondary	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	No
Secondary	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	No
Secondary	OCT		Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84	No
Secondary	Fluorescein Angiography (FA)		Time frame 24 months (Screening, Day 7, Day 14, Day 28, Day 84 and Month 24)	No