Diabetic Macular EdemaPhase 4NCT01309451
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
A Phase 4 study testing Bevacizumab and dexamethasone intravitreal implant in people with Diabetic Macular Edema, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Bevacizumab and dexamethasone intravitreal implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 years or older
- Type 1 or type 2 diabetes
- BCVA score of >24 and <78 letters
- Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns
Who cannot join
- Anti-VEGF intravitreal treatment in last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks
- PRP or Focal laser in last 4 months
- Active iris neovascularization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
- Conditions
- Diabetic Macular Edema
- Being tested
- Bevacizumab, dexamethasone intravitreal implant
- Keywords
- diabetic macular edema, DME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
intravitreal, 1.25mg., monthly
dexamethasone intravitreal implantDrug
Also called Ozurdex
0.7mg, intravitreal every 4 months
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab alone | Active comparator | Not described Receives: Drug: Bevacizumab |
| Combined group | Active comparator | Bevacizumab plus Ozurdex Receives: Drug: Bevacizumab; Drug: dexamethasone intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Measured: baseline to 12 month
OCT CST
change in optical coherence tomography central subfield thickness
Measured: change in OCT CST from baseline to twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 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 Diabetic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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, Midwest Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309451
- Sponsor's protocol ID
- OA002
- Status last verified
- Oct 2014
- First submitted
- 3 Mar 2011
- Last updated
- 29 Oct 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 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Masked, Randomized Controlled Study to Assess Efficacy of Ozurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01309451
- Acronym / sponsor ID
- OA002
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, DME
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab alone | Active comparator | Drug: Bevacizumab |
| Combined group | Active comparator | Drug: Bevacizumab, Drug: dexamethasone intravitreal implantBevacizumab plus Ozurdex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female age 18 years or older
- Type 1 or type 2 diabetes
- BCVA score of >24 and <78 letters
- Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) >250microns
Key exclusion criteria (4 listed)
- Anti-VEGF intravitreal treatment in last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks
- PRP or Focal laser in last 4 months
- Active iris neovascularization
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 |
|---|---|---|
| BevacizumabAlso: Avastinintravitreal, 1.25mg., monthly | Drug | Bevacizumab alone, Combined group |
| dexamethasone intravitreal implantAlso: Ozurdex0.7mg, intravitreal every 4 months | Drug | Combined group |
Primary outcome
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Time frame: baseline to 12 month
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
OCT CST
Time frame: change in OCT CST from baseline to twelve months
change in optical coherence tomography central subfield thickness
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- 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.
Raj K Maturi, MD principal investigator
Midwest Eye Institute
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 Bevacizumab and dexamethasone intravitreal implant in people with Diabetic Macular Edema, 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 4 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 29 Oct 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 29 Oct 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 in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline (time frame: baseline to 12 month). 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 29 Oct 2014.