Branch Retinal Vein Occlusion with Macular EdemaPhase 4NCT03709745
Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion
A Phase 4 study testing Aflibercept Injection [Eylea] and Ranibizumab Injection [Lucentis] in people with Branch Retinal Vein Occlusion with Macular Edema, run by St. Erik Eye Hospital at 1 site in Sweden.
Trial summary
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion with Macular Edema
- What is being tested?
- Aflibercept Injection [Eylea] and Ranibizumab Injection [Lucentis]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 18 Oct 2018to 10 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT > 300 micrometers (Cirrus)
Who cannot join
- BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular stroke during the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing Treatment with Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.
Read the detailed description
One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm.
At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.
- Being tested
- Aflibercept Injection [Eylea], Ranibizumab Injection [Lucentis]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection [Eylea]Drug
Also called Eylea
Intravitreal injection is given as described in the arm description
Ranibizumab Injection [Lucentis]Drug
Also called Lucentis
Intravitreal injection is given as described in the arm description
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Active comparator | Aflibercept is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen. Receives: Drug: Aflibercept Injection [Eylea] |
| Ranibizumab | Active comparator | Ranibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen. Receives: Drug: Ranibizumab Injection [Lucentis] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time to recurrence of macular edema
Time, in weeks, from completion of loading dose to first recurrence of macular edema.
Measured: 9 months
Secondary outcomes (3)
Comparison of the number of patients without ME in each treatment arm at one month after the first injection
The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared
Measured: 1 month
Comparison of the number of injections needed in each treatment arm to resolve ME
The number of injections needed for macular edema to resolve in each treatment arm are compared
Measured: 9 months
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start18 Oct 2018
- Primary completion15 Oct 2021
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein Occlusion with 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Erik Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Kvanta, St. Erik Eye Hospital
- Investigators
- Anders Kvanta, MD PhD, Principal investigator, St. Erik Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709745
- Sponsor's protocol ID
- 2017/2422-31
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2018
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Treatment with Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT03709745
- Acronym / sponsor ID
- 2017/2422-31
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- St. Erik Eye HospitalUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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.
Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.
Detailed description
One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm.
At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Active comparator | Drug: Aflibercept Injection [Eylea]Aflibercept is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen. |
| Ranibizumab | Active comparator | Drug: Ranibizumab Injection [Lucentis]Ranibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT > 300 micrometers (Cirrus)
Key exclusion criteria (1 listed)
- BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular stroke during the last 3 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 |
|---|---|---|
| Aflibercept Injection [Eylea]Also: EyleaIntravitreal injection is given as described in the arm description | Drug | Aflibercept |
| Ranibizumab Injection [Lucentis]Also: LucentisIntravitreal injection is given as described in the arm description | Drug | Ranibizumab |
Primary outcome
Difference in time to recurrence of macular edema
Time frame: 9 months
Time, in weeks, from completion of loading dose to first recurrence of macular edema.
3 secondary outcomes
Comparison of the number of patients without ME in each treatment arm at one month after the first injection
Time frame: 1 month
Comparison of the number of injections needed in each treatment arm to resolve ME
Time frame: 9 months
Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs.
Time frame: 9 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 28 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Branch Retinal Vein Occlusion with Macular Edema
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Neovascular Age-Related Macular Degeneration (NVAMD), Branch Retinal Vein Occlusion (BRVO)
Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration
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.
Anders Kvanta, MD PhD principal investigator
St. Erik Eye Hospital
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 Aflibercept Injection [Eylea] and Ranibizumab Injection [Lucentis] in people with Branch Retinal Vein Occlusion with Macular Edema, run by St. Erik Eye Hospital at 1 site in Sweden.
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 1 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 28 Oct 2024. 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 Sweden. 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?
Difference in time to recurrence of macular edema (time frame: 9 months). 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 28 Oct 2024.