Retinal Vein OcclusionPhase 4NCT01427751
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
A Phase 4 study testing dexamethasone intravitreal implant and ranibizumab in people with Retinal Vein Occlusion and Macular Edema, run by Allergan at 6 sites in 6 countries.
Trial summary
This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- dexamethasone intravitreal implant and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 11 Oct 2011to 4 Nov 2014
- 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
- Diagnosis of branch retinal vein occlusion in at least one eye
- Visual acuity between 20/400 to 20/40
Who cannot join
- Active eye infection
- Ocular hypertension which is not controlled on monotherapy (one medication)
- Anticipated need for eye surgery during the study
- Cataract surgery in either eye within 3 months
- Eye surgery including laser of any type within 6 months
- Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
- Use of ocular steroids within 3 months
- Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- dexamethasone intravitreal implant, ranibizumab
- Medical subject headings
- Retinal Vein Occlusion, 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®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
ranibizumabBiological
Also called Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
| Study group | Role | What they receive |
|---|---|---|
| Ozurdex® | Active comparator | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. Receives: Drug: dexamethasone intravitreal implant |
| Lucentis® | Active comparator | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria. Receives: Biological: ranibizumab |
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)
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
Measured: Baseline, Month 12
Secondary outcomes (6)
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.
Measured: Baseline, Month 12
Percentage of Patients With 15-or-More Letter Improvement in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Measured: Baseline, Month 12
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Measured: Baseline, Month 12
Time to BCVA Improvement of 15-or-More Letters
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Measured: 12 Months
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Measured: Baseline, Month 12
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study start11 Oct 2011
- Primary completion4 Nov 2014
- Study completion4 Nov 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 307 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
- NCT01427751
- Sponsor's protocol ID
- MAF-AGN-OPH-RET-004
- Other IDs
- 2010-023900-29
- Status last verified
- Apr 2019
- First submitted
- 31 Aug 2011
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.
PubMed 29631435
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01427751
- Acronym / sponsor ID
- MAF-AGN-OPH-RET-004
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2011 (actual)
- Primary completion
- 4 Nov 2014 (actual)
- Study completion
- 4 Nov 2014 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 15 Feb 2016
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 safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
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 implantInjection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. |
| Lucentis® | Active comparator | Biological: ranibizumabInjection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of branch retinal vein occlusion in at least one eye
- Visual acuity between 20/400 to 20/40
Key exclusion criteria (8 listed)
- Active eye infection
- Ocular hypertension which is not controlled on monotherapy (one medication)
- Anticipated need for eye surgery during the study
- Cataract surgery in either eye within 3 months
- Eye surgery including laser of any type within 6 months
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: Ozurdex®Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. | Drug | Ozurdex® |
| ranibizumabAlso: Lucentis®Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria. | Biological | Lucentis® |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Month 12
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
6 secondary outcomes
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
Time frame: Baseline, Month 12
Percentage of Patients With 15-or-More Letter Improvement in BCVA
Time frame: Baseline, Month 12
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
Time frame: Baseline, Month 12
Time to BCVA Improvement of 15-or-More Letters
Time frame: 12 Months
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
Time frame: Baseline, Month 12
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29631435Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.
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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
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone intravitreal implant and ranibizumab in people with Retinal Vein Occlusion and Macular Edema, run by Allergan at 6 sites in 6 countries.
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 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 18 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 6 sites in France, Germany, Israel, Italy, Spain and 1 more country. 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 15 Feb 2016). 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) (time frame: Baseline, Month 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 NCT01427751, 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 18 Apr 2019.