Retinal Vein OcclusionPhase 4INTRAMED-CRVONCT06416241
Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion
A Phase 4 study testing EYLEA 2 MG in 0.05 ML Injection in people with Retinal Vein Occlusion and Vascular Occlusive Disease, run by University of Athens.
Trial summary
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Vein Occlusion, Vascular Occlusive Disease
- What is being tested?
- EYLEA 2 MG in 0.05 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Mar 2024
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
- Patients >18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
- BCVA of Snellen of 20/40 to 20/200 in the study eye
Who cannot join
- Previous PRP or macular laser photocoagulation in the study eye.
- Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
- Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
- Any active or previous inflammation, ocular trauma
- Uncontrolled glaucoma (IOP>30 mmHg)
About this study
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.
Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.
The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.
- Conditions
- Retinal Vein Occlusion, Vascular Occlusive Disease
- Being tested
- EYLEA 2 MG in 0.05 ML Injection
- Keywords
- optical coherence tomography angiography, aflibercept, retinal vein occlusion, biomarkers
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYLEA 2 MG in 0.05 ML InjectionDrug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Eylea 2.0mg/0.05ml | Other | Not described Receives: Drug: EYLEA 2 MG in 0.05 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity as measured using ETDRS charts
Measured: 5 years
Change in retinal thickness as measured in μm using spectral domain optical coherence tomography
Measured: 5 years
Secondary outcomes (3)
Change in microvascular parameters in OCT angiography (vessel density, FAZ area)
Measured: 2 years
Complications
Measured: 5 years
Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irini Chatziralli, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416241
- Sponsor's protocol ID
- 699/2019
- Acronym
- INTRAMED-CRVO
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept for Macular Edema Due to Central Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT06416241
- Acronym / sponsor ID
- INTRAMED-CRVO / 699/2019
- Conditions
- Retinal Vein Occlusion, Vascular Occlusive Disease
- Keywords
- optical coherence tomography angiography, aflibercept, retinal vein occlusion, biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 16 May 2024 (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.
Central retinal vein occlusion (CRVO) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. CRVO may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion.
Aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials.
The purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. Additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eylea 2.0mg/0.05ml | Other | Drug: EYLEA 2 MG in 0.05 ML Injection |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Treatment naive center-involved macular edema secondary to CRVO for no longer than 3 months.
- Patients >18 years of age, who are diagnosed with macular edema secondary to CRVO who are scheduled to be treated with intravitreal aflibercept in real-life conditions
- BCVA of Snellen of 20/40 to 20/200 in the study eye
Key exclusion criteria (5 listed)
- Previous PRP or macular laser photocoagulation in the study eye.
- Any prior ocular treatment in the study eye for macular edema secondary to CRVO.
- Prior systemic anti-VEGF or corticosteroid therapy, within the last 3 months before enrollment to the study.
- Any active or previous inflammation, ocular trauma
- Uncontrolled glaucoma (IOP>30 mmHg)
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 |
|---|---|---|
| EYLEA 2 MG in 0.05 ML InjectionIntravitreal injection | Drug | Eylea 2.0mg/0.05ml |
Primary outcome
Change in visual acuity as measured using ETDRS charts
Time frame: 5 years
Change in retinal thickness as measured in μm using spectral domain optical coherence tomography
Time frame: 5 years
3 secondary outcomes
Change in microvascular parameters in OCT angiography (vessel density, FAZ area)
Time frame: 2 years
Complications
Time frame: 5 years
Change in endothelial dysfunctionafter aflibercept treatment, as measured by the perfused boundary region sublingual 5-25 μm
Time frame: 6 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 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EYLEA 2 MG in 0.05 ML Injection in people with Retinal Vein Occlusion and Vascular Occlusive Disease, run by University of Athens.
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 3 inclusion and 5 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in visual acuity as measured using ETDRS charts (time frame: 5 years). 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?
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 16 May 2024.