Retinal Vein Occlusion (RVO)NCT01946399
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
A study testing Ozurdex implant in people with Retinal Vein Occlusion (RVO) and Macular Edema, run by Retina Research Institute, LLC at 1 site in United States.
Trial summary
To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response. 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 (RVO), Macular Edema
- What is being tested?
- Ozurdex implant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.
Who cannot join
- Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
- Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
- Pregnancy
- Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
- Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
- Advanced glaucoma
Show all 9Show fewer
- Aphakic eyes with rupture or missing posterior lens capsule
- Eyes with anterior chamber intraocular lens and missing posterior lens capsule
- Patients with known hypersensitivity to components of this product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications
To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.
Read the detailed description
To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.
- Conditions
- Retinal Vein Occlusion (RVO), Macular Edema
- Being tested
- Ozurdex implant
- 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.
Ozurdex implantDrug
Also called Dexamethasone implant
Intravitreal injection of Dexamethasone implant
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex implant | Other | Intravitreal injection of Ozurdex implant Receives: Drug: Ozurdex implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
Measured: 6 Months
Secondary outcomes (1)
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion1 Sep 2016
- Study completion1 Sep 2017
Why it stopped: enrollment not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein Occlusion (RVO)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Research Institute, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.
- Responsible party
- Principal investigator, Rhonda Weeks, Retina Research Institute, LLC
- Investigators
- Gaurav K Shah, MD, Principal investigator, Retina Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946399
- Sponsor's protocol ID
- Ozurdex RVO 2013
- Status last verified
- Nov 2017
- First submitted
- 16 Sep 2013
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications
- ClinicalTrials.gov ID
- NCT01946399
- Acronym / sponsor ID
- Ozurdex RVO 2013
- Conditions
- Retinal Vein Occlusion (RVO), Macular Edema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment not met
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Retina Research Institute, LLCUniversity, hospital or other
- Collaborators
- Retina-Vitreous Associates Medical Group, West Coast Retina Medical Group, Inc.
- Study start
- Sep 2013
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.
Detailed description
To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ozurdex implant | Other | Drug: Ozurdex implantIntravitreal injection of Ozurdex implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.
Key exclusion criteria (9 listed)
- Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
- Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
- Pregnancy
- Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
- Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
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 |
|---|---|---|
| Ozurdex implantAlso: Dexamethasone implantIntravitreal injection of Dexamethasone implant | Drug | Ozurdex implant |
Primary outcome
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy
Time frame: 6 Months
1 secondary outcome
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: enrollment not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
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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.
Gaurav K Shah, MD principal investigator
Retina Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozurdex implant in people with Retinal Vein Occlusion (RVO) and Macular Edema, run by Retina Research Institute, LLC 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Dec 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.
Are results available for this study?
The study was stopped early (reason given: enrollment not met). Results are not available in the source record.
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?
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy (time frame: 6 Months). 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 2 Dec 2017.