Retinal Vein OcclusionsPhase 4NCT01085734
Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
A Phase 4 study testing Avastin and Osurdex in people with Retinal Vein Occlusions, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes 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 Occlusions
- What is being tested?
- Avastin and Osurdex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Oct 2011
- Phase
- Phase 4
- 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
- male or female age 18 years or older
- Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
- Best correct visual acuity of greater than 24 and less than 80
- Presence of macular edema defined as OCT central subfield thickness of >250
Who cannot join
- intravitreal anti-VEGF treatment in study eye within six weeks of baseline
- intravitreal steroid treatment in the study eye within eight weeks of baseline visit
- PRP in the study eye within 4 month of baseline visit
- Active iris neovascularization in study eye
- Uncontrolled systemic disease
- Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
- Conditions
- Retinal Vein Occlusions
- Being tested
- Avastin, Osurdex
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
1.25mg intravitreally
OsurdexDrug
0.7mg intravitreally
AvastinDrug
1.25mg intravitreally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema Receives: Drug: Avastin |
| Group 2 | Active comparator | Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema Receives: Drug: Osurdex; Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Visual Acuity at 6 Months
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Measured: 6 months
Secondary outcomes (2)
Number of Injections Needed
number of Avastin and Ozurdex injections needed
Measured: baseline to 6 months
Change in Macular Thickness and Macular Volume
OCT central subfield thickness measured in microns
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 posted12 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionOct 2011
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 OcclusionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Responsible party
- Principal investigator, Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
- Investigators
- Raj K Maturi, MD, Principal investigator, Raj K. Maturi, MD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085734
- Sponsor's protocol ID
- OA001
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2010
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Single Site, Masked, Randomized,Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01085734
- Acronym / sponsor ID
- OA001
- Conditions
- Retinal Vein Occlusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Mar 2010 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: AvastinGroup 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema |
| Group 2 | Active comparator | Drug: Osurdex, Drug: AvastinGroup 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female age 18 years or older
- Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
- Best correct visual acuity of greater than 24 and less than 80
- Presence of macular edema defined as OCT central subfield thickness of >250
Key exclusion criteria (6 listed)
- intravitreal anti-VEGF treatment in study eye within six weeks of baseline
- intravitreal steroid treatment in the study eye within eight weeks of baseline visit
- PRP in the study eye within 4 month of baseline visit
- Active iris neovascularization in study eye
- Uncontrolled systemic disease
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 |
|---|---|---|
| Avastin1.25mg intravitreally | Drug | Group 1 |
| Osurdex0.7mg intravitreally | Drug | Group 2 |
| Avastin1.25mg intravitreally | Drug | Group 2 |
Primary outcome
Change From Baseline Visual Acuity at 6 Months
Time frame: 6 months
Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
2 secondary outcomes
Number of Injections Needed
Time frame: baseline to 6 months
Change in Macular Thickness and Macular Volume
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Retinal Vein Occlusions
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
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.
Raj K Maturi, MD principal investigator
Raj K. Maturi, MD, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avastin and Osurdex in people with Retinal Vein Occlusions, run by Maturi, Raj K., M.D., P.C. 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 4 inclusion and 6 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 21 Apr 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 21 Apr 2014). 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?
Change From Baseline Visual Acuity at 6 Months (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 21 Apr 2014; AzTrials last refreshed its copy on 30 Oct 2026.