Macular EdemaNCT01231633
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
A study testing Ozurdex and Avastin in people with Macular Edema and Central Retinal Vein Occlusion, run by Long Island Vitreoretinal Consultants at 4 sites in United States.
Trial summary
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Central Retinal Vein Occlusion
- What is being tested?
- Ozurdex and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2010to Sep 2014
- Phase
- Interventional
- 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
- Presence of central retinal vein occlusion (CRVO)
- Age 18 years or older
- ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
- OCT Central foveal thickness >250 microns
- Negative pregnancy test for women of childbearing potential
- Ability to provide written informed consent
- Capable of complying with study protocol
Who cannot join
- History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication
- History of steroid-related glaucoma (steroid response)
- Previous intraocular injection of steroid medication within 90 days
- Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
- Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
- Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
Show all 12Show fewer
- Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
- Dense cataract that precludes clinical examination and retinal imaging of the retina
- History of allergy to dexamethasone, bevacizumab, betadine
- Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
- Unwilling or unable to follow or comply with all study related procedures
- Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788
Long Island Vitreoretinal Consultants
Riverhead, New York, 11901
Retina Vitreous Center
Toms River, New Jersey, 08755
About this study
Official title: Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
- Conditions
- Macular Edema, Central Retinal Vein Occlusion
- Being tested
- Ozurdex, Avastin
- Keywords
- Macular Edema, Central Retinal Vein Occlusion
- 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.
OzurdexDrug
Also called Dexamethasone implant
Ozurdex, 0.7mg dexamethasone
AvastinDrug
Also called Avastin, bevacizumab
Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. Receives: Drug: Ozurdex; Drug: Avastin |
| Group 2 | Active comparator | Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Measured: Baseline - Month 6
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Measured: Baseline - Month 6
Secondary outcomes (1)
Change in Central Mean Thickness Based on OCT
Change in Central Mean Thickness based on OCT from baseline to Month 6t
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2014
- Study completionSep 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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Long Island Vitreoretinal Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants
- Investigators
- Vincent A Deramo, M.D, Principal investigator, Long Island Vitreoretinal Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231633
- Sponsor's protocol ID
- IST CRVO 1118147
- Status last verified
- Mar 2018
- First submitted
- 28 Oct 2010
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT01231633
- Acronym / sponsor ID
- IST CRVO 1118147
- Conditions
- Macular Edema, Central Retinal Vein Occlusion
- Keywords
- Macular Edema, Central Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Long Island Vitreoretinal ConsultantsUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Ozurdex, Drug: AvastinSubjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed. |
| Group 2 | Active comparator | Drug: AvastinSubjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of central retinal vein occlusion (CRVO)
- Age 18 years or older
- ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
- OCT Central foveal thickness >250 microns
- Negative pregnancy test for women of childbearing potential
Key exclusion criteria (12 listed)
- History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication
- History of steroid-related glaucoma (steroid response)
- Previous intraocular injection of steroid medication within 90 days
- Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
- Evidence of significant retinal ischemia on fluorescein angiography 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 implantOzurdex, 0.7mg dexamethasone | Drug | Group 1 |
| AvastinAlso: Avastin, bevacizumabFormulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed. | Drug | Group 1, Group 2 |
Primary outcome
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
Time frame: Baseline - Month 6
The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Time frame: Baseline - Month 6
Total Number of addiitonal Avastin injections during study- From baseline to Month 6
1 secondary outcome
Change in Central Mean Thickness Based on OCT
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- 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.
Vincent A Deramo, M.D principal investigator
Long Island Vitreoretinal Consultants
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozurdex and Avastin in people with Macular Edema and Central Retinal Vein Occlusion, run by Long Island Vitreoretinal Consultants at 4 sites 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 12 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 3 Apr 2018). 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?
The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm (time frame: Baseline - Month 6). 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 3 Apr 2018.