Macular EdemaPhase 3NCT01660802
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
A Phase 3 study testing 700 μg Dexamethasone in people with Macular Edema, run by Allergan at 1 site in China.
Trial summary
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- 700 μg Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2012to 20 May 2014
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Who cannot join
- History of glaucoma, ocular hypertension or optic nerve head change
- Any active bacterial, viral, parasitic, or fungal infections in either eye
- Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
- History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
- Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
- Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
- Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
- Conditions
- Macular Edema
- Being tested
- 700 μg Dexamethasone, Sham
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
700 μg DexamethasoneDrug
Also called Ozurdex®
700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
ShamOther
Sham administered in the study eye on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 700 μg Dexamethasone | Experimental | 700 μg Dexamethasone intravitreal injection in the study eye on Day 1. Receives: Drug: 700 μg Dexamethasone |
| Sham | Sham comparator | Sham administered in the study eye on Day 1. Receives: Drug: 700 μg Dexamethasone; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 are presented.
Measured: Baseline, 6 Months
Secondary outcomes (3)
Average Change From Baseline in 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) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Measured: Baseline, 6 Months
Change From Baseline in 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) in the study eye. 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. A decrease in the number of letters read correctly (negative number) means that vision has worsened.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline 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) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start4 Sep 2012
- Primary completion31 Mar 2014
- Study completion20 May 2014
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 262 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
- NCT01660802
- Sponsor's protocol ID
- 206207-020
- Status last verified
- Apr 2019
- First submitted
- 7 Aug 2012
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.
PubMed 29119239
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT01660802
- Acronym / sponsor ID
- 206207-020
- Conditions
- Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2012 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 20 May 2014 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 8 Jun 2015
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 assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 700 μg Dexamethasone | Experimental | Drug: 700 μg Dexamethasone700 μg Dexamethasone intravitreal injection in the study eye on Day 1. |
| Sham | Sham comparator | Drug: 700 μg Dexamethasone, Other: ShamSham administered in the study eye on Day 1. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Key exclusion criteria (7 listed)
- History of glaucoma, ocular hypertension or optic nerve head change
- Any active bacterial, viral, parasitic, or fungal infections in either eye
- Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
- History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
- Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
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: Ozurdex®700 μg Dexamethasone intravitreal injection in the study eye on Day 1. | Drug | 700 μg Dexamethasone, Sham |
| ShamSham administered in the study eye on Day 1. | Other | Sham |
Primary outcome
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, 6 Months
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 are presented.
3 secondary outcomes
Average Change From Baseline in BCVA in the Study Eye
Time frame: Baseline, 6 Months
Change From Baseline in BCVA in the Study Eye
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29119239Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 700 μg Dexamethasone in people with Macular Edema, run by Allergan at 1 site in China.
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 1 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 17 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 1 site in China. 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 8 Jun 2015). 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?
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, 6 Months). 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 NCT01660802, 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 17 Apr 2019.