Macular EdemaPhase 3NCT00168324
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
A Phase 3 study testing 700 µg Dexamethasone and 350 µg Dexamethasone in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 13 sites in 13 countries.
Trial summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion. 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?
- 700 µg Dexamethasone and 350 µg Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 599 participants
- Where
- 13 sitesin 13 countries
- Study dates
- 1 Oct 2004to 1 Oct 2008
- Phase
- Phase 3
- 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
- 18 years of age or older with macular edema resulting from retinal vein occlusion
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- Visual acuity in other eye no worse than 20/200
Who cannot join
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Diabetic retinopathy
- Uncontrolled systemic disease
- Known steroid-responder
- Use of systemic steroids
- Use of warfarin/heparin
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
About this study
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- 700 µg Dexamethasone, 350 µg Dexamethasone, Sham Injection
- 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.
700 µg DexamethasoneDrug
Also called Posurdex®
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg DexamethasoneDrug
Also called Posurdex®
350 µg Dexamethasone intravitreal implant administered on Day 0.
Sham InjectionOther
Sham injection on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| 700 µg Dexamethasone | Experimental | 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. Receives: Drug: 700 µg Dexamethasone |
| 350 µg Dexamethasone followed by 700 µg Dexamethasone | Experimental | 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. Receives: Drug: 700 µg Dexamethasone; Drug: 350 µg Dexamethasone |
| Sham Injection followed by 700 µg Dexamethasone | Sham comparator | Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. Receives: Drug: 700 µg Dexamethasone; Other: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Response Rate of 15 or More Letter Improvement
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
Measured: Up to 180 Days
Secondary outcomes (4)
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.
Measured: Day 90, Day 180
Change From Baseline in Retinal Thickness in the Study Eye
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, Day 90, Day 180
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Measured: Baseline, Day 90
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Measured: Baseline, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study start1 Oct 2004
- Primary completion1 Mar 2008
- Study completion1 Oct 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 599 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
- NCT00168324
- Sponsor's protocol ID
- 206207-008
- Status last verified
- Apr 2019
- First submitted
- 12 Sep 2005
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
PubMed 20417567
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00168324
- Acronym / sponsor ID
- 206207-008
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2004 (actual)
- Primary completion
- 1 Mar 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 26 Aug 2009
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 an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 700 µg Dexamethasone | Experimental | Drug: 700 µg Dexamethasone700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. |
| 350 µg Dexamethasone followed by 700 µg Dexamethasone | Experimental | Drug: 700 µg Dexamethasone, Drug: 350 µg Dexamethasone350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
| Sham Injection followed by 700 µg Dexamethasone | Sham comparator | Drug: 700 µg Dexamethasone, Other: Sham InjectionSham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older with macular edema resulting from retinal vein occlusion
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- Visual acuity in other eye no worse than 20/200
Key exclusion criteria (7 listed)
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Diabetic retinopathy
- Uncontrolled systemic disease
- Known steroid-responder
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 |
|---|---|---|
| 700 µg DexamethasoneAlso: Posurdex®700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. | Drug | 350 µg Dexamethasone followed by 700 µg Dexamethasone, 700 µg Dexamethasone, Sham Injection followed by 700 µg Dexamethasone |
| 350 µg DexamethasoneAlso: Posurdex®350 µg Dexamethasone intravitreal implant administered on Day 0. | Drug | 350 µg Dexamethasone followed by 700 µg Dexamethasone |
| Sham InjectionSham injection on Day 0. | Other | Sham Injection followed by 700 µg Dexamethasone |
Primary outcome
Cumulative Response Rate of 15 or More Letter Improvement
Time frame: Up to 180 Days
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
4 secondary outcomes
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Day 90, Day 180
Change From Baseline in Retinal Thickness in the Study Eye
Time frame: Baseline, Day 90, Day 180
Percentage of Patients With a Change From Baseline in BCVA by Category
Time frame: Baseline, Day 90
Percentage of Patients With a Change From Baseline in BCVA by Category
Time frame: Baseline, Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20417567Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
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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
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 700 µg Dexamethasone and 350 µg Dexamethasone in people with Macular Edema and Retinal Vein Occlusion, run by Allergan at 13 sites in 13 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 3 inclusion and 7 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 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Australia, Austria, Canada, Czechia and 8 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Aug 2009). 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?
Cumulative Response Rate of 15 or More Letter Improvement (time frame: Up to 180 Days). 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 NCT00168324, 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 23 Apr 2019.