Diabetic Macular EdemaPhase 4NCT02036424
Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
A Phase 4 study testing Ozurdex and Bevacizumab in people with Diabetic Macular Edema, run by Raj K. Maturi, MD at 1 site in United States.
Trial summary
To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more… 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?
- Ozurdex and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2015
- 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 of female age 18 years or older
- Type 1 or Type 2 diabetes
- Best corrected visual acuity (BCVA) score of >24 and <78 letters
- History of at least 3 anti-VEGF intravitreal injections over the past 5 months
- Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT
Who cannot join
- Anti-VEGF intravitreal treatment in the last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
- Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
- Active iris neovascularization
- Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
- Uncontrolled systemic disease
Show all 13Show fewer
- Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
- Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
- Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
- Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Aphakia or pseudophakia with anterior chamber intraocular lens
- Hypersensitivity to any components of Ozurdex or Avastin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.
Read the detailed description
Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ozurdex, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone Intravitreal Implant
intravitreal steroid
BevacizumabDrug
Also called Avastin
antiVEGF
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Active comparator | 1.25 mg intravitreal injection given monthly during a 6 month period Receives: Drug: Bevacizumab |
| Ozurdex | Active comparator | Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Receives: Drug: Ozurdex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Visual Acuity Change
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
Measured: baseline to month 7
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
Measured: baseline to month seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionAug 2015
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raj K. Maturi, MD
- Collaborators
- Allergan
- Responsible party
- Sponsor-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
- NCT02036424
- Sponsor's protocol ID
- OA 003
- Status last verified
- Nov 2015
- First submitted
- 13 Jan 2014
- Last updated
- 1 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02036424
- Acronym / sponsor ID
- OA 003
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Raj K. Maturi, MD
- Collaborators
- Allergan
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 3 Nov 2015
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 there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.
Detailed description
Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Active comparator | Drug: Bevacizumab1.25 mg intravitreal injection given monthly during a 6 month period |
| Ozurdex | Active comparator | Drug: OzurdexDexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male of female age 18 years or older
- Type 1 or Type 2 diabetes
- Best corrected visual acuity (BCVA) score of >24 and <78 letters
- History of at least 3 anti-VEGF intravitreal injections over the past 5 months
- Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT
Key exclusion criteria (13 listed)
- Anti-VEGF intravitreal treatment in the last 4 weeks
- Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
- Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
- Active iris neovascularization
- Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
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 Intravitreal Implantintravitreal steroid | Drug | Ozurdex |
| BevacizumabAlso: AvastinantiVEGF | Drug | Bevacizumab |
Primary outcome
Mean Visual Acuity Change
Time frame: baseline to month 7
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Time frame: baseline to month seven
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
- 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
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 Ozurdex and Bevacizumab in people with Diabetic Macular Edema, run by Raj K. Maturi, MD 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 5 inclusion and 13 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 1 Dec 2015. 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 3 Nov 2015). 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?
Mean Visual Acuity Change (time frame: baseline to month 7). 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 1 Dec 2015.