Retinal Vein OcclusionPhase 3NCT01449682
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
A Phase 3 study testing Ozurdex in people with Retinal Vein Occlusion and Macular Edema, run by Retina Macula Institute at 1 site in United States.
Trial summary
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- Ozurdex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Feb 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
- Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
- Age 18 years or older
- ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
- Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
- For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.
- Ability to provide written informed consent • Capable of complying with study protocol
Who cannot join
- History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
- Intraocular injection of steroid medication within prior 4 months
- Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
- Previous laser photocoagulation within 4 months of study
- Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
Read the detailed description
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- Ozurdex
- Keywords
- BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone implant, DEX implant
0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
OzurdexDrug
Also called dexamethasone implant, DEX implant
0.7 mg intravitreal DEX implant on first visit then every 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex PRN | Active comparator | 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Receives: Drug: Ozurdex |
| Ozurdex Q16 weeks | Active comparator | 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Receives: Drug: Ozurdex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Function Using Microperimetry
To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
Measured: baseline to 48 weeks
Macular Function Using Multi-focal ERG
To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
Measured: baseline to 48 weeks
Secondary outcomes (2)
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Measured: baseline to 48 weeks
To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Measured: baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 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 Retinal Vein OcclusionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Macula Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Ron P Gallemore, M.D. Ph.D, Principal investigator, Retina Macula InstituteBehnam Sharareh, B.S, Study director, Retina Macula Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449682
- Sponsor's protocol ID
- IIT-287
- Status last verified
- Apr 2017
- First submitted
- 6 Oct 2011
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
- ClinicalTrials.gov ID
- NCT01449682
- Acronym / sponsor ID
- IIT-287
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Keywords
- BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Retina Macula InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
Detailed description
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozurdex PRN | Active comparator | Drug: Ozurdex0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT |
| Ozurdex Q16 weeks | Active comparator | Drug: Ozurdex0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)
- Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.
- Age 18 years or older
- ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800
- Central foveal thickness >275 microns or presence of cystic edema on OCT studies.
Key exclusion criteria (7 listed)
- History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.
- Intraocular injection of steroid medication within prior 4 months
- Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.
- Previous laser photocoagulation within 4 months of study
- Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician
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 |
|---|---|---|
| OzurdexAlso: Dexamethasone implant, DEX implant0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies | Drug | Ozurdex PRN |
| OzurdexAlso: dexamethasone implant, DEX implant0.7 mg intravitreal DEX implant on first visit then every 16 weeks | Drug | Ozurdex Q16 weeks |
Primary outcome
Macular Function Using Microperimetry
Time frame: baseline to 48 weeks
To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
Macular Function Using Multi-focal ERG
Time frame: baseline to 48 weeks
To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
2 secondary outcomes
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time frame: baseline to 48 weeks
To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time frame: baseline to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ron P Gallemore, M.D. Ph.D principal investigator
Retina Macula Institute
Behnam Sharareh, B.S study director
Retina Macula Institute
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 Ozurdex in people with Retinal Vein Occlusion and Macular Edema, run by Retina Macula Institute at 1 site in United States.
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 7 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 31 May 2017. 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 United States. 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 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 31 May 2017). 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?
Macular Function Using Microperimetry (time frame: baseline to 48 weeks). The study lists 2 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 31 May 2017.