Macular Edema Caused by Retinal Vein OcclusionPhase 4NCT01767545

Dexamethasone-implant for the Treatment of RVO

A Phase 4 study testing Dexamethasone implant and Bevacizumab in people with Macular Edema Caused by Retinal Vein Occlusion, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

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

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Macular Edema Caused by Retinal Vein Occlusion
What is being tested?: Dexamethasone implant and Bevacizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteGermany
Study dates: Sep 2010to Feb 2012
Phase: Phase 4
Are there results?: None posted in the registry

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 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -

Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dept. of Ophthalmology, LMU Munich
Munich, 80336

Other trials in Germany

About this study

Official title: Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion

To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.

Conditions: Macular Edema Caused by Retinal Vein Occlusion
Being tested: Dexamethasone implant, Bevacizumab

What participants receive

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

Dexamethasone implantDrug
BevacizumabDrug

Study groups in NCT01767545
Study group	Role	What they receive
Dexamethasone-implant (Group 1)	Active comparator	Group 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning. Receives: Drug: Dexamethasone implant
Bevacizumab/Dexamethasone-implant (Group 2)	Active comparator	Group 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection. Receives: Drug: Dexamethasone implant; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
Measured: 12 months

Secondary outcomes (3)

Central retinal thickness
Measured: 12 months
Lens opacity
Measured: 12 months
Saftey of procedure
Measured: 12 months

Timeline

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

Sep 2010Feb 2012

First posted14 Jan 2013 (estimated)
Study startSep 2010
Primary completionJan 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Macular Edema Caused by Retinal Vein OcclusionStudies 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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01767545
Sponsor's protocol ID: Mayer-DEX-001
Status last verified: Jan 2013
First submitted: 9 Jan 2013
Last updated: 14 Jan 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Twelve Months Experience With a Dexamethasone-implant for the Treatment of Macular Edema Associated With Retinal Vein Occlusion
ClinicalTrials.gov ID: NCT01767545
Acronym / sponsor ID: Mayer-DEX-001
Conditions: Macular Edema Caused by Retinal Vein Occlusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Ludwig-Maximilians - University of MunichUniversity, hospital or other
Study start: Sep 2010
Primary completion: Jan 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 14 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dexamethasone-implant (Group 1)	Active comparator	Drug: Dexamethasone implantGroup 1 included 38 patients (22 with CRVO and 16 with BRVO) and was treated with a dexamethasone-implant injection from the beginning.
Bevacizumab/Dexamethasone-implant (Group 2)	Active comparator	Drug: Dexamethasone implant, Drug: BevacizumabGroup 2 included 26 patients (14 CRVO, 12 BRVO) and was treated with three consecutive injections of bevacizumab at a monthly interval, followed by a dexamethasone-implant injection four weeks after the last bevacizumab injection.

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 implant	Drug	Bevacizumab/Dexamethasone-implant (Group 2), Dexamethasone-implant (Group 1)
Bevacizumab	Drug	Bevacizumab/Dexamethasone-implant (Group 2)

Primary outcome

The primary clinical endpoint was BCVA twelve months after the first intravitreal treatment.
Time frame: 12 months

3 secondary outcomes

Central retinal thickness
Time frame: 12 months
Lens opacity
Time frame: 12 months
Saftey of procedure
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Dexamethasone implant and Bevacizumab in people with Macular Edema Caused by Retinal Vein Occlusion, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 14 Jan 2013. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 primary clinical endpoint was BCVA twelve months after the first intravitreal treatment. (time frame: 12 months). 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 NCT01767545.

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 14 Jan 2013.