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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00363714 |
Recruitment Status :
Completed
First Posted : August 15, 2006
Last Update Posted : August 18, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-Related Macular Degeneration Choroidal Neovascularization | Drug: AGN211745 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Single intravitreal injection
|
Drug: AGN211745
100microgram single intravitreal injection
Other Name: Sirna-027 |
Experimental: 2
Single intravitreal injection
|
Drug: AGN211745
200microgram single intravitreal injection
Other Name: Sirna-027 |
Experimental: 3
Single intravitreal injection
|
Drug: AGN211745
400microgram single intravitreal injection
Other Name: Sirna-027 |
Experimental: 4
Single intravitreal injection
|
Drug: AGN211745
800microgram single intravitreal injection
Other Name: Sirna-027 |
Experimental: 5
Single intravitreal injection
|
Drug: AGN211745
1200microgram single intravitreal injection
Other Name: Sirna-027 |
Experimental: 6
Single intravitreal injection
|
Drug: AGN211745
1600microgram single intravitreal injection
Other Name: Sirna-027 |
- Adverse Events [ Time Frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84 ]
- 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 ]
- 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 ]
- OCT [ Time Frame: 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) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363714
United States, Maryland | |
Baltimore, Maryland, United States | |
United States, Ohio | |
Cleveland, Ohio, United States |
Study Director: | Medical Director | Allergan |
Responsible Party: | Therapeutic Area Head, Allergan, Inc. |
ClinicalTrials.gov Identifier: | NCT00363714 |
Obsolete Identifiers: | NCT00495742 |
Other Study ID Numbers: |
SIRNA 0401 AGN211745 |
First Posted: | August 15, 2006 Key Record Dates |
Last Update Posted: | August 18, 2008 |
Last Verified: | August 2008 |
Macular Degeneration Choroidal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases |
Eye Diseases Metaplasia Pathologic Processes Choroid Diseases Uveal Diseases |