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Age-Related Macular DegenerationPhase 1/2NCT00363714

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)

A Phase 1/2 study testing AGN211745 in people with Age-Related Macular Degeneration and Choroidal Neovascularization, run by Allergan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
AGN211745
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
Nov 2004to Apr 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Cleveland, Ohio

Other trials in United States

About this study

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.

Being tested
AGN211745
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGN211745Drug

    Also called Sirna-027

    100microgram single intravitreal injection

  • AGN211745Drug

    Also called Sirna-027

    200microgram single intravitreal injection

  • AGN211745Drug

    Also called Sirna-027

    400microgram single intravitreal injection

  • AGN211745Drug

    Also called Sirna-027

    800microgram single intravitreal injection

  • AGN211745Drug

    Also called Sirna-027

    1200microgram single intravitreal injection

  • AGN211745Drug

    Also called Sirna-027

    1600microgram single intravitreal injection

Study groups in NCT00363714
Study groupRoleWhat they receive
1ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745
2ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745
3ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745
4ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745
5ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745
6ExperimentalSingle intravitreal injection
Receives: Drug: AGN211745

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

Secondary outcomes (4)

  1. Visual Acuity using the Diabetic Retinopathy Study chart

    Measured: 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

    Measured: 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

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

  4. Fluorescein Angiography (FA)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363714
Sponsor's protocol ID
SIRNA 0401
Other IDs
AGN211745
Status last verified
Aug 2008
First submitted
10 Aug 2006
Last updated
18 Aug 2008
Results posted
No

Publications

  • 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.

    PubMed 20609706

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AGN211745 in people with Age-Related Macular Degeneration and Choroidal Neovascularization, run by Allergan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00363714, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2008.

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