Macular EdemaPhase 1/2NCT01027650

Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)

A Phase 1/2 study testing AGN208397 intravitreal injection and dexamethasone intravitreal implant in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 5 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Edema, Retinal Vein Occlusion
What is being tested?: AGN208397 intravitreal injection and dexamethasone intravitreal implant
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 5 sitesin 5 countries
Study dates: Mar 2010to Feb 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

macular edema due to retinal vein occlusion
visual acuity in the study eye between 20/320 to 20/40

Who cannot join

cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
use of injectable drugs in the study eye within 2 months prior to day 1
active eye infection in either eye
visual acuity in the non-study eye of 20/200 or worse

Trial locations and contacts

5 sites in 5 countries.

Country

City, postcode or hospital

5 sites in 5 countries

United States1 site

Study site
Phoenix, Arizona

Other trials in United States

Australia1 site

Study site
East Melbourne, Victoria

Other trials in Australia

Canada1 site

Study site
London, Ontario

Other trials in Canada

Israel1 site

Study site
Tel Aviv

Other trials in Israel

South Africa1 site

Study site
Cape Town

Other trials in South Africa

About this study

This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.

Conditions: Macular Edema, Retinal Vein Occlusion
Being tested: AGN208397 intravitreal injection, dexamethasone intravitreal implant
Medical subject headings: Macular Edema, Retinal Vein Occlusion

What participants receive

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

AGN208397 intravitreal injectionDrug
AGN208397 intravitreal injection on Day 1.
dexamethasone intravitreal implantDrug
Also called Ozurdex®
Dexamethasone 700 ug intravitreal implant on Day 1.

Study groups in NCT01027650
Study group	Role	What they receive
Stage 1 Cohort 1	Experimental	AGN208397 intravitreal injection 75 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 1 Cohort 2	Experimental	AGN208397 intravitreal injection 300 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 1 Cohort 3	Experimental	AGN208397 intravitreal injection 600 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 1 Cohort 4	Experimental	AGN208397 intravitreal injection 900 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 2 Arm 1	Experimental	AGN208397 intravitreal injection 600 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 2 Arm 2	Experimental	AGN208397 intravitreal injection 450 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 2 Arm 3	Experimental	AGN208397 intravitreal injection 300 ug on Day 1. Receives: Drug: AGN208397 intravitreal injection
Stage 2 Arm 4	Active comparator	Dexamethasone 700 ug intravitreal implant on Day 1. Receives: Drug: dexamethasone intravitreal implant

What is being measured

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

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Measured: Baseline, Month 1
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Measured: Baseline, Month 1
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Month 1
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Month 1

Secondary outcomes (4)

Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Measured: Baseline, Month 12
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Measured: Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Measured: Baseline, Month 12

Timeline

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

Mar 2010Feb 2013

First posted8 Dec 2009 (estimated)
Study startMar 2010
Primary completionApr 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Macular EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01027650
Sponsor's protocol ID: 208397-001
Status last verified: Mar 2014
First submitted: 4 Dec 2009
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

All Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
ClinicalTrials.gov ID: NCT01027650
Acronym / sponsor ID: 208397-001
Conditions: Macular Edema, Retinal Vein Occlusion
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Apr 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 8 Dec 2009 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Stage 1 Cohort 1	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 75 ug on Day 1.
Stage 1 Cohort 2	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 300 ug on Day 1.
Stage 1 Cohort 3	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 600 ug on Day 1.
Stage 1 Cohort 4	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 900 ug on Day 1.
Stage 2 Arm 1	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 600 ug on Day 1.
Stage 2 Arm 2	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 450 ug on Day 1.
Stage 2 Arm 3	Experimental	Drug: AGN208397 intravitreal injectionAGN208397 intravitreal injection 300 ug on Day 1.
Stage 2 Arm 4	Active comparator	Drug: dexamethasone intravitreal implantDexamethasone 700 ug intravitreal implant on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

macular edema due to retinal vein occlusion
visual acuity in the study eye between 20/320 to 20/40

Key exclusion criteria (4 listed)

cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months)
use of injectable drugs in the study eye within 2 months prior to day 1
active eye infection in either eye
visual acuity in the non-study eye of 20/200 or worse

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGN208397 intravitreal injectionAGN208397 intravitreal injection on Day 1.	Drug	Stage 1 Cohort 1, Stage 1 Cohort 2, Stage 1 Cohort 3, Stage 1 Cohort 4, Stage 2 Arm 1, Stage 2 Arm 2, Stage 2 Arm 3
dexamethasone intravitreal implantAlso: Ozurdex®Dexamethasone 700 ug intravitreal implant on Day 1.	Drug	Stage 2 Arm 4

Primary outcome

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Time frame: Baseline, Month 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Time frame: Baseline, Month 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
Time frame: Baseline, Month 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
Time frame: Baseline, Month 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

4 secondary outcomes

Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Time frame: Baseline, Month 12
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Time frame: Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Time frame: Baseline, Month 12
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Time frame: Baseline, Month 12

Results and safety

Results posted to the registry on 29 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Cohort 4	6	6
Stage 1 Cohort 3	6	6
Stage 1 Cohort 2	6	6
Stage 1 Cohort 1	3	3
Stage 2 Arm 1	25	23
Stage 2 Arm 2	26	24
Stage 2 Arm 3	25	24
Stage 2 Arm 4	24	24

Primary outcome: Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1

Time frame: Baseline, Month 1. Mean (Standard Deviation). Unit: Microns

Measure	Stage 1 Cohort 4 n = 6	Stage 1 Cohort 3 n = 6	Stage 1 Cohort 2 n = 6	Stage 1 Cohort 1 n = 3
Baseline	500.2 (197.58)	495.8 (163.13)	499.5 (158.33)	468.3 (24.34)
Change from Baseline at Month 1	-234.3 (200.23)	-210.5 (173.69)	-256.2 (102.61)	-206.7 (96.40)

Population analysed: Safety Population: all patients who received study treatment

Primary outcome: Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2

Time frame: Baseline, Month 1. Mean (Standard Deviation). Unit: Microns

Measure	Stage 2 Arm 1 n = 23	Stage 2 Arm 2 n = 25	Stage 2 Arm 3 n = 21	Stage 2 Arm 4 n = 23
Baseline	612.6 (166.15)	637.8 (203.69)	597.9 (217.54)	679.7 (237.20)
Change from Baseline at Month 1	-298.5 (174.59)	-314.1 (169.35)	-307.0 (217.98)	-317.3 (212.51)

Population analysed: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye

Primary outcome: Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1

Time frame: Baseline, Month 1. Mean (Standard Deviation). Unit: Number of Letters Read Correctly

Measure	Stage 1 Cohort 4 n = 6	Stage 1 Cohort 3 n = 6	Stage 1 Cohort 2 n = 6	Stage 1 Cohort 1 n = 3
Baseline	54.5 (16.13)	50.2 (14.12)	59.7 (6.62)	53.0 (9.54)
Change from Baseline at Month 1	10.0 (8.72)	11.7 (7.17)	8.7 (4.84)	9.7 (2.31)

Population analysed: Safety Population: all patients who received study treatment

Primary outcome: Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2

Time frame: Baseline, Month 1. Mean (Standard Deviation). Unit: Number of Letters Read Correctly

Measure	Stage 2 Arm 1 n = 23	Stage 2 Arm 2 n = 25	Stage 2 Arm 3 n = 22	Stage 2 Arm 4 n = 23
Baseline	49.5 (12.88)	47.6 (13.60)	58.2 (12.89)	50.5 (14.27)
Change from Baseline at Month 1	12.0 (9.38)	12.5 (12.74)	14.0 (12.35)	11.0 (11.99)

Population analysed: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 Cohort 4	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Stage 1 Cohort 3	0 of 6 (0%)	6 of 6 (100%)	Not reported
Stage 1 Cohort 2	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Stage 1 Cohort 1	0 of 3 (0%)	3 of 3 (100%)	Not reported
Stage 2 Arm 1	4 of 25 (16%)	25 of 25 (100%)	Not reported
Stage 2 Arm 2	4 of 26 (15.4%)	26 of 26 (100%)	Not reported
Stage 2 Arm 3	2 of 25 (8%)	25 of 25 (100%)	Not reported
Stage 2 Arm 4	3 of 24 (12.5%)	24 of 24 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

5 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AGN208397 intravitreal injection and dexamethasone intravitreal implant in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 5 sites in 5 countries.

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 2 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Australia, Canada, Israel, South Africa. 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?

Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 (time frame: Baseline, Month 1). The study lists 4 primary outcomes in all. 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 NCT01027650.

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 29 Apr 2014.