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.
Trial summary
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… Read more about this study
- 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.
5 sites in 5 countries
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
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
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.
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.
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
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.