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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)

Primary Purpose

Age-Related Macular Degeneration, Choroidal Neovascularization

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AGN211745

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm Description

Single intravitreal injection

Outcomes

Primary Outcome Measures

Adverse Events

Secondary Outcome Measures

Visual Acuity using the Diabetic Retinopathy Study chart

IOP

OCT

Fluorescein Angiography (FA)

Full Information

NCT ID

NCT00363714

First Posted

August 10, 2006

Last Updated

August 14, 2008

Sponsor

Allergan

Collaborators

Sirna Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00363714

Brief Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Allergan

Collaborators

Sirna Therapeutics Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Macular Degeneration, Choroidal Neovascularization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Arm Title

Arm Type

Experimental

Arm Description

Single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

100microgram single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

200microgram single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

400microgram single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

800microgram single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

1200microgram single intravitreal injection

Intervention Type

Drug

Intervention Name(s)

AGN211745

Other Intervention Name(s)

Sirna-027

Intervention Description

1600microgram single intravitreal injection

Primary Outcome Measure Information:

Title

Adverse Events

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

OCT

Time Frame

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

Title

Fluorescein Angiography (FA)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Baltimore

State/Province

Maryland

Country

United States

City

Cleveland

State/Province

Ohio

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20609706

Citation

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.

Results Reference

derived

Learn more about this trial

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)

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