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CompletedNCT01027650Updated Apr 29, 2014Results posted

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

A Phase 1/2 interventional study of AGN208397 intravitreal injection and dexamethasone intravitreal implant in Macular Edema and Retinal Vein Occlusion, sponsored by Allergan. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-29.

Sponsored by Allergan · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Macular Edema
  • Retinal Vein Occlusion
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 121 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Stage 1 Cohort 1

    AGN208397 intravitreal injection 75 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 1 Cohort 2

    AGN208397 intravitreal injection 300 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 1 Cohort 3

    AGN208397 intravitreal injection 600 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 1 Cohort 4

    AGN208397 intravitreal injection 900 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 2 Arm 1

    AGN208397 intravitreal injection 600 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 2 Arm 2

    AGN208397 intravitreal injection 450 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Experimental
    Stage 2 Arm 3

    AGN208397 intravitreal injection 300 ug on Day 1.

    Drug: AGN208397 intravitreal injection

  • Active comparator
    Stage 2 Arm 4

    Dexamethasone 700 ug intravitreal implant on Day 1.

    Drug: dexamethasone intravitreal implant

Interventions

  • DrugAGN208397 intravitreal injection

    AGN208397 intravitreal injection on Day 1.

  • Drugdexamethasone intravitreal implant

    Dexamethasone 700 ug intravitreal implant on Day 1.

    Also known as: Ozurdex®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Month 1

  2. 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.

    Time frame: Baseline, Month 1

  3. 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.

    Time frame: Baseline, Month 1

  4. 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.

    Time frame: Baseline, Month 1

Secondary outcomes

  1. 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.

    Time frame: Baseline, Month 12

  2. 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.

    Time frame: Baseline, Month 12

  3. 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.

    Time frame: Baseline, Month 12

  4. 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.

    Time frame: Baseline, Month 12

07

Results

Posted Apr 29, 2014

Participant flow

Participant flow — Overall Study
MilestoneStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1Stage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Started666325262524
Completed666323242424
Not completed00002210
Withdrew: Personal reasons00002100
Withdrew: Lost to follow-up00000010
Withdrew: Lack of efficacy00000100

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Month 1
Reported as:
Mean · Microns
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
MicronsStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1
Baseline500.2 ± 197.58495.8 ± 163.13499.5 ± 158.33468.3 ± 24.34
Change from Baseline at Month 1-234.3 ± 200.23-210.5 ± 173.69-256.2 ± 102.61-206.7 ± 96.40
PrimaryChange 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.

Time frame:
Baseline, Month 1
Reported as:
Mean · Microns
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
MicronsStage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Baseline612.6 ± 166.15637.8 ± 203.69597.9 ± 217.54679.7 ± 237.20
Change from Baseline at Month 1-298.5 ± 174.59-314.1 ± 169.35-307.0 ± 217.98-317.3 ± 212.51
PrimaryChange 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.

Time frame:
Baseline, Month 1
Reported as:
Mean · Number of Letters Read Correctly
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
Number of Letters Read CorrectlyStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1
Baseline54.5 ± 16.1350.2 ± 14.1259.7 ± 6.6253.0 ± 9.54
Change from Baseline at Month 110.0 ± 8.7211.7 ± 7.178.7 ± 4.849.7 ± 2.31
PrimaryChange 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.

Time frame:
Baseline, Month 1
Reported as:
Mean · Number of Letters Read Correctly
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
Number of Letters Read CorrectlyStage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Baseline49.5 ± 12.8847.6 ± 13.6058.2 ± 12.8950.5 ± 14.27
Change from Baseline at Month 112.0 ± 9.3812.5 ± 12.7414.0 ± 12.3511.0 ± 11.99
SecondaryChange 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.

Time frame:
Baseline, Month 12
Reported as:
Mean · Microns
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
MicronsStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1
Baseline500.2 ± 197.58495.8 ± 163.13499.5 ± 158.33468.3 ± 24.34
Change from Baseline at Month 12 (N=3, 3, 3, 3)-221.7 ± 208.33-173.0 ± 145.01-239.7 ± 121.33-167.7 ± 96.72
SecondaryChange 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.

Time frame:
Baseline, Month 12
Reported as:
Mean · Microns
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
MicronsStage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Baseline612.6 ± 166.15637.8 ± 203.69597.9 ± 217.54679.7 ± 237.20
Change from Baseline at Month 12-252.8 ± 177.09-218.0 ± 166.57-208.2 ± 200.48-169.1 ± 213.50
SecondaryChange 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.

Time frame:
Baseline, Month 12
Reported as:
Mean · Number of Letters Read Correctly
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Number of Letters Read CorrectlyStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1
Baseline54.5 ± 16.1350.2 ± 14.1259.7 ± 6.6253.0 ± 9.54
Change from Baseline at Month 12 (N=6, 5, 6, 3)14.2 ± 15.300.8 ± 24.8811.0 ± 7.4314.0 ± 5.29
SecondaryChange 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.

Time frame:
Baseline, Month 12
Reported as:
Mean · Number of Letters Read Correctly
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Number of Letters Read CorrectlyStage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Baseline49.5 ± 12.8847.6 ± 13.6058.2 ± 12.8950.5 ± 14.27
Change from Baseline at Month 128.0 ± 13.5510.2 ± 17.2212.4 ± 14.315.0 ± 11.18

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stage 1 Cohort 4—1/6 (16.7%)6/6 (100%)
Stage 1 Cohort 3—0/6 (0%)6/6 (100%)
Stage 1 Cohort 2—1/6 (16.7%)6/6 (100%)
Stage 1 Cohort 1—0/3 (0%)3/3 (100%)
Stage 2 Arm 1—4/25 (16%)25/25 (100%)
Stage 2 Arm 2—4/26 (15.4%)26/26 (100%)
Stage 2 Arm 3—2/25 (8%)25/25 (100%)
Stage 2 Arm 4—3/24 (12.5%)24/24 (100%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1Stage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
GlioblastomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/60/60/60/30/250/260/250/24
Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/60/61/60/30/250/260/250/24
Benign Prostatic HyperplasiaReproductive system and breast disorders0/40/40/30/20/151/150/120/12
Myocardial IschaemiaCardiac disorders0/60/60/60/30/250/260/251/24
PneumoniaInfections and infestations0/60/60/60/30/250/260/251/24
RhabdomyolysisMusculoskeletal and connective tissue disorders0/60/60/60/30/250/260/251/24
VasculitisVascular disorders0/60/60/60/30/250/260/251/24
Ankle FractureInjury, poisoning and procedural complications0/60/60/60/31/250/260/250/24
Cardiac Failure CongestiveCardiac disorders0/60/60/60/31/250/260/250/24
CholelithiasisHepatobiliary disorders0/60/60/60/31/250/260/250/24
Most frequent other events
Showing 10 of 113
Most frequent other events
EventStage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1Stage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4
Intraocular Pressure IncreasedInvestigations4/63/61/60/36/258/269/255/24
Retinal HaemorrhageEye disorders2/61/64/62/34/257/266/253/24
Conjunctival HaemorrhageEye disorders2/63/62/61/36/256/264/259/24
Cystoid Macular OedemaEye disorders1/60/63/60/31/251/263/253/24
Vulvovaginal PruritusReproductive system and breast disorders1/20/20/30/10/100/110/130/12
Visual Acuity ReducedEye disorders0/63/61/60/33/255/260/253/24
Benign Prostatic HyperplasiaReproductive system and breast disorders0/40/40/31/20/151/150/121/12
Macular OedemaEye disorders0/61/61/60/33/255/265/2511/24
CataractEye disorders2/62/61/60/31/254/261/251/24
Blood Urea IncreasedInvestigations2/60/60/60/30/250/260/251/24

Baseline characteristics

Age, Customized
Age, Customized(Participants)Stage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1Stage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4Total
<45 years1000033310
Between 45 and 65 years344081011949
>65 years22231713111262
Sex: Female, Male
Sex: Female, Male(Participants)Stage 1 Cohort 4Stage 1 Cohort 3Stage 1 Cohort 2Stage 1 Cohort 1Stage 2 Arm 1Stage 2 Arm 2Stage 2 Arm 3Stage 2 Arm 4Total
Female22311011131254
Male44321515121267
08

Study locations

5 sites
  • Phoenix, Arizona, United States
  • East Melbourne, Victoria, Australia
  • London, Ontario, Canada
  • Tel Aviv, Israel
  • Cape Town, South Africa
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01027650
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Dec 8, 2009
Start date
Mar 2010
Primary completion
Apr 2012
Completion
Feb 2013
Results posted
Apr 29, 2014
Last update
Apr 29, 2014

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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