Macular EdemaNCT01571557
A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
An observational study of Macular Edema and Retinal Vein Occlusion, run by Allergan at 1 site in Germany.
Trial summary
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- What is being tested?
- dexamethasone 700 ug intravitreal implant
- How many people
- 573 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2012to 30 Jun 2014
- Phase
- Observational
- 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
Study population: Patients with macular oedema due to retinal vein occlusion
Who may be able to join
- Diagnosis of macular edema following retinal vein occlusion
- Prescribed OZURDEX®
Who cannot join
- Previous treatment with OZURDEX®
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- dexamethasone 700 ug intravitreal implant
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 700 ug intravitreal implantDrug
Also called OZURDEX®
dexamethasone 700 ug intravitreal implant administered according to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| OZURDEX® | OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care. Receives: Drug: dexamethasone 700 ug intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.
Measured: Baseline, Week 12
Secondary outcomes (3)
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.
Measured: Baseline, 48 Weeks
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.
Measured: Baseline, 48 Weeks
Mean Change From Baseline in Central Retinal Thickness
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study start30 Apr 2012
- Primary completion31 Mar 2014
- Study completion30 Jun 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571557
- Sponsor's protocol ID
- MAF/AGN/OPH/RET/011
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2012
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.
PubMed 25503473
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
- ClinicalTrials.gov ID
- NCT01571557
- Acronym / sponsor ID
- MAF/AGN/OPH/RET/011
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OZURDEX® | – | Drug: dexamethasone 700 ug intravitreal implantOZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with macular oedema due to retinal vein occlusion
Key inclusion criteria (2 listed)
- Diagnosis of macular edema following retinal vein occlusion
- Prescribed OZURDEX®
Key exclusion criteria (1 listed)
- Previous treatment with OZURDEX®
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 700 ug intravitreal implantAlso: OZURDEX®dexamethasone 700 ug intravitreal implant administered according to standard of care. | Drug | OZURDEX® |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Week 12
BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.
3 secondary outcomes
Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
Time frame: Baseline, 48 Weeks
Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
Time frame: Baseline, 48 Weeks
Mean Change From Baseline in Central Retinal Thickness
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25503473Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema and Retinal Vein Occlusion, run by Allergan 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?
The sponsor lists 2 inclusion and 1 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 19 Apr 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, Week 12). 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 NCT01571557, which also lists 1 linked publication.
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 19 Apr 2019.