Branch Retinal Vein Occlusion With Macular EdemaPhase 4NCT03405376
Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion
A Phase 4 study testing Intravitreal aflibercept injection in people with Branch Retinal Vein Occlusion With Macular Edema, run by Yeungnam University College of Medicine at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept injection for treatment of macular edema secondary to 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?
- Intravitreal aflibercept injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 25 Jan 2018to 30 Sep 2020
- 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
- Center-involved macular edema secondary to BRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
- Adult subjects diagnosed with macular edema secondary to BRVO who are scheduled to be treated with intravitreal aflibercept as per investigator's routine treatment practice with the intent to use a T\&E regimen after initial treatment.
- Treatment-naïve subjects for macular edema secondary to BRVO.
- Both ischemic and non-ischemic BRVO, which are confirmed by FA at baselin, week 24 and week 72.
- Men and women ≥ 18 years of age.
- Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.
Who cannot join
- Previous PRP or macular laser photocoagulation in the study eye.
- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to BRVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
- Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
- Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
- Any history of allergy to povidone iodine.
- Known serious allergy to the fluorescein sodium for injection in angiography.
- Presence of any contraindications indicated in the EU commission/locally approved label for intravitreal aflibercept: hypersensitivity to the active substance intravitreal aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Dong-A University Hospital
Busan
Woo Jin Jung, MD
- Recruiting
Maryknoll Medical Center
Busan
Jung Min Park, MD
- Recruiting
Min Sagong
Daegu, Deagu, 42415
Min Sagong, MD, 82-53-620-3443, msagong@ynu.ac.kr
- Recruiting
Chungnam National University Hospital
Daejeon
Jung Yeul Kim, MD
- Recruiting
Chonnam National University Hospital
Gwangju
Yong-Sok Ji, MD
About this study
Official title: Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion: the PLATON Trial
The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept injection for treatment of macular edema secondary to BRVO.
Read the detailed description
Retinal vein occlusion (RVO) includes central RVO (CRVO) and branch RVO (BRVO). A highly prevalent retinal vascular disease, RVO is second only to diabetic retinopathy. In CRVO, hemorrhages and edema develop throughout the retina, whereas in BRVO the pathology is more sectoral, involving the portions of the retina drained by the obstructed branch vein. This suggests that increased intraluminal pressure behind the obstruction may lead to transudation of blood cells and plasma into the retina. However, recent studies have demonstrated that although increased venous pressure may be the precipitating event for hemorrhages and edema, increased production of vascular endothelial growth factor (VEGF) occurs early in RVO and is a major contributor to their evolution and persistence. In addition, the high levels of VEGF contribute to progression of retinal nonperfusion and hence retinal ischemia, which may in turn increase production of VEGF, and may explain why some eyes enter a vicious cycle of worsening disease often referred to as conversion to an ischemic RVO.
Treat-and-extend intravitreal anti-VEGF with age related macular degeneration and diabetic macular edema has been reported to offer the opportunity to individual management while minimizing treatment burden and similar visual and anatomical outcomes to those with fixed montly dosing.
Also, small retrospective treat-and-extend intravitreal bevacizumab injection for treatment of BRVO associated macular edema demonstrated similar visual outcomes and number of intravitreal injections as did pro-re-nata treatment with ranibizumab conducted in phase 3 trials but with fewer visits and lower annual medical costs.
The effects of afilbercept have been reported to persist for over 8 weeks in DME and AMD studies. In addition, VIBRANT study also demonstrated that bi-monthly injection of aflibercept showed significant visual improvement in BRVO patients.
In the treat-and-extend studies of RVO, ranibizumab has been extended for up to 4 months at intervals of 2 weeks. But, to our knowledge, there was no prospective study of treat-and-extend regiments with intravitreal aflibercept in treatment naïve patients in BRVO.
- Being tested
- Intravitreal aflibercept injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal aflibercept injectionDrug
Also called Eylea, VEGF Trap-Eye
Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Branch retinal vein occlusion | Experimental | Aflibercept 2mg is injected into the vitreous cavity. Center-involved macular edema secondary to branch retinal vein occlusion for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit) Receives: Drug: Intravitreal aflibercept injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of best corrected visual acuity
The mean change of best corrected visual acuity from baseline to Week 72 in early treatment diabetic retinopathy letter score
Measured: From baseline to Week 72
Secondary outcomes (6)
Mean change of best corrected visual acuity
The change in mean best corrected visual acuity at baseline as measured by the early treatment diabetic retinopathy letter score
Measured: From baseline to Week 24, 52
mean change in central macular thickness
The mean change in central macular thickness
Measured: From baseline to Weeks 24, 52, and 72
mean treatment interval between injections
The mean treatment interval between injections
Measured: From baseline to Week 72
gain ≥ 15 letters in best corrected visual acuity
The proportion of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart
Measured: Compared with baseline at Week 24, 52 and 72
mean treatment interval between injections of ≥ 12 or 16 weeks
The proportion of subjects with a mean treatment interval between injections of ≥ 12 or 16 weeks
Measured: From the last actual visit of the initiation phase to Week 72
who reach 16 weeks treatment interval at any time point
The proportion of subjects who reach 16 weeks treatment interval at any time point
Measured: up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start25 Jan 2018
- Primary completion31 Mar 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Sagong, Yeungnam University College of Medicine
- Investigators
- Min Sagong, MD, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405376
- Sponsor's protocol ID
- YUMC2017-07-056-003
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion: the PLATON Trial
- ClinicalTrials.gov ID
- NCT03405376
- Acronym / sponsor ID
- YUMC2017-07-056-003
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 23 Jan 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.
The purpose of this study is to evaluate the efficacy and safety of the treat-and-extend regimen extending to 4 months by intervals of 4 weeks using intravitreal aflivercept injection for treatment of macular edema secondary to BRVO.
Detailed description
Retinal vein occlusion (RVO) includes central RVO (CRVO) and branch RVO (BRVO). A highly prevalent retinal vascular disease, RVO is second only to diabetic retinopathy. In CRVO, hemorrhages and edema develop throughout the retina, whereas in BRVO the pathology is more sectoral, involving the portions of the retina drained by the obstructed branch vein. This suggests that increased intraluminal pressure behind the obstruction may lead to transudation of blood cells and plasma into the retina. However, recent studies have demonstrated that although increased venous pressure may be the precipitating event for hemorrhages and edema, increased production of vascular endothelial growth factor (VEGF) occurs early in RVO and is a major contributor to their evolution and persistence. In addition, the high levels of VEGF contribute to progression of retinal nonperfusion and hence retinal ischemia, which may in turn increase production of VEGF, and may explain why some eyes enter a vicious cycle of worsening disease often referred to as conversion to an ischemic RVO.
Treat-and-extend intravitreal anti-VEGF with age related macular degeneration and diabetic macular edema has been reported to offer the opportunity to individual management while minimizing treatment burden and similar visual and anatomical outcomes to those with fixed montly dosing.
Also, small retrospective treat-and-extend intravitreal bevacizumab injection for treatment of BRVO associated macular edema demonstrated similar visual outcomes and number of intravitreal injections as did pro-re-nata treatment with ranibizumab conducted in phase 3 trials but with fewer visits and lower annual medical costs.
The effects of afilbercept have been reported to persist for over 8 weeks in DME and AMD studies. In addition, VIBRANT study also demonstrated that bi-monthly injection of aflibercept showed significant visual improvement in BRVO patients.
In the treat-and-extend studies of RVO, ranibizumab has been extended for up to 4 months at intervals of 2 weeks. But, to our knowledge, there was no prospective study of treat-and-extend regiments with intravitreal aflibercept in treatment naïve patients in BRVO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Branch retinal vein occlusion | Experimental | Drug: Intravitreal aflibercept injectionAflibercept 2mg is injected into the vitreous cavity. Center-involved macular edema secondary to branch retinal vein occlusion for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Center-involved macular edema secondary to BRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
- Adult subjects diagnosed with macular edema secondary to BRVO who are scheduled to be treated with intravitreal aflibercept as per investigator's routine treatment practice with the intent to use a T\&E regimen after initial treatment.
- Treatment-naïve subjects for macular edema secondary to BRVO.
- Both ischemic and non-ischemic BRVO, which are confirmed by FA at baselin, week 24 and week 72.
- Men and women ≥ 18 years of age.
Key exclusion criteria (8 listed)
- Previous PRP or macular laser photocoagulation in the study eye.
- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to BRVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
- Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
- Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
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 |
|---|---|---|
| Intravitreal aflibercept injectionAlso: Eylea, VEGF Trap-EyeAflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion. | Drug | Branch retinal vein occlusion |
Primary outcome
Mean change of best corrected visual acuity
Time frame: From baseline to Week 72
The mean change of best corrected visual acuity from baseline to Week 72 in early treatment diabetic retinopathy letter score
6 secondary outcomes
Mean change of best corrected visual acuity
Time frame: From baseline to Week 24, 52
mean change in central macular thickness
Time frame: From baseline to Weeks 24, 52, and 72
mean treatment interval between injections
Time frame: From baseline to Week 72
gain ≥ 15 letters in best corrected visual acuity
Time frame: Compared with baseline at Week 24, 52 and 72
mean treatment interval between injections of ≥ 12 or 16 weeks
Time frame: From the last actual visit of the initiation phase to Week 72
who reach 16 weeks treatment interval at any time point
Time frame: up to 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Related trials for Branch Retinal Vein Occlusion With Macular Edema
RecruitingPhase 2
A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO
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.
Min Sagong, MD principal investigator
Yeungnam University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravitreal aflibercept injection in people with Branch Retinal Vein Occlusion With Macular Edema, run by Yeungnam University College of Medicine at 5 sites in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Sagong, MD (82-53-620-3443, msagong@ynu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of best corrected visual acuity (time frame: From baseline to Week 72). 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 9 Jan 2019.