Diabetic Macular EdemaPhase 2NCT01571232

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

A Phase 2 study testing dexamethasone intravitreal implant and intravitreal bevacizumab in people with Diabetic Macular Edema and Non-proliferative Diabetic Retinopathy, run by Retina Macula Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
What is being tested?: dexamethasone intravitreal implant and intravitreal bevacizumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Mar 2015
Phase: Phase 2
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 NPDR or PDR as confirmed by fluorescein angiography
Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections
Age 18 years or older
ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)
Ability to provide written informed consent
Capable of complying with study protocol.

Who cannot join

Intraocular injection of steroid medication within prior 3 months
Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
Prior vitrectomy surgery
Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.
Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
Patients who are pregnant.
Unwilling or unable to follow or comply with all study related procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Retina Macula Institute
Torrance, California, 90503

Other trials in United States

About this study

Official title: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.

Read the detailed description

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Conditions: Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
Being tested: dexamethasone intravitreal implant, intravitreal bevacizumab
Keywords: Macular Edema, DME, PDR, NPDR, Ozurdex, Dexamethasone, Avastin, Bevacizumab
Medical subject headings: Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dexamethasone intravitreal implantDrug
Also called Ozurdex
Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
intravitreal bevacizumabDrug
Also called Avastin
Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.

Study groups in NCT01571232
Study group	Role	What they receive
Ozurdex	Active comparator	Patients in this group receive Ozurdex at initial visit and at month 4 Receives: Drug: dexamethasone intravitreal implant
Avastin	Active comparator	Patients in this group receive Avastin Q1 month for 5 months. Receives: Drug: intravitreal bevacizumab

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 Letters).
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
Measured: 6 months
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
Measured: 6 months

Secondary outcomes (3)

The Change in Macular Leakage on Fluorescein Angiography From Baseline
To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
Measured: 6 months
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
Measured: 6 months
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Mar 2015

First posted5 Apr 2012 (estimated)
Study startApr 2012
Primary completionFeb 2014
Study completionMar 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01571232
Sponsor's protocol ID: IIT-406
Status last verified: Mar 2021
First submitted: 2 Apr 2012
Last updated: 30 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
ClinicalTrials.gov ID: NCT01571232
Acronym / sponsor ID: IIT-406
Conditions: Diabetic Macular Edema, Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy
Keywords: Macular Edema, DME, PDR, NPDR, Ozurdex, Dexamethasone, Avastin, Bevacizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Retina Macula InstituteUniversity, hospital or other
Collaborators: Allergan
Study start: Apr 2012
Primary completion: Feb 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 5 Apr 2012 (estimated)
Results: Posted 31 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ozurdex	Active comparator	Drug: dexamethasone intravitreal implantPatients in this group receive Ozurdex at initial visit and at month 4
Avastin	Active comparator	Drug: intravitreal bevacizumabPatients in this group receive Avastin Q1 month for 5 months.

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 NPDR or PDR as confirmed by fluorescein angiography
Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections
Age 18 years or older
ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)

Key exclusion criteria (8 listed)

Intraocular injection of steroid medication within prior 3 months
Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
Prior vitrectomy surgery
Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.

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
dexamethasone intravitreal implantAlso: OzurdexOzurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Drug	Ozurdex
intravitreal bevacizumabAlso: AvastinAvastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.	Drug	Avastin

Primary outcome

The Change in Visual Acuity (Number of ETDRS Letters).
Time frame: 6 months
The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Time frame: 6 months
The measure the change in central foveal thickness for each treatment group from baseline to 6 months.

3 secondary outcomes

The Change in Macular Leakage on Fluorescein Angiography From Baseline
Time frame: 6 months
The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Time frame: 6 months
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Time frame: 6 months

Results and safety

Results posted to the registry on 31 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ozurdex	10	9
Avastin	10	9

Primary outcome: The Change in Visual Acuity (Number of ETDRS Letters).

Time frame: 6 months. Mean (Standard Error). Unit: ETDRS letters

Measure	Ozurdex n = 9	Avastin n = 10
Baseline	67.8 (3.8)	71.9 (2.9)
Final Visit	69.6 (4.8)	72.9 (3.4)

Primary outcome: The Change in Central Foveal Thickness (Microns on High Resolution OCT).

Time frame: 6 months. Mean (Standard Error). Unit: microns

Measure	Ozurdex n = 9	Avastin n = 10
Baseline	385.9 (43.0)	341.5 (11.3)
Final Visit	305.4 (9.1)	324.3 (10.9)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ozurdex	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Avastin	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

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.

Ron P Gallemore, M.D, Ph.D principal investigator

Retina Macula Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 30 Mar 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 31 May 2017). 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 Letters). (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT01571232.

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 30 Mar 2021.