Prospective Trial of Treat and Extend Aflibercept for Macular Edema Secondary to Branch Retinal Vein Occlusion

NCT ID: NCT03405376

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2020-09-30

Brief 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.

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.

Conditions

Branch Retinal Vein Occlusion With Macular Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Branch retinal vein occlusion

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)

Group Type: EXPERIMENTAL

Intravitreal aflibercept injection

Intervention Type: DRUG

Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.

Interventions

Intravitreal aflibercept injection

Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.

Intervention Type: DRUG

Other Intervention Names

Eylea, VEGF Trap-Eye

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yeungnam University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Min Sagong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min Sagong, MD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

Locations

Min Sagong

Daegu, Deagu, South Korea

Site Status: RECRUITING

Dong-A University Hospital

Busan, , South Korea

Site Status: RECRUITING

Maryknoll Medical Center

Busan, , South Korea

Site Status: RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status: RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Sagong, MD

Role: CONTACT

msagong@ynu.ac.kr

82-53-620-3443

Jinhee Kim

Role: CONTACT

ey001@ymc.yu.ac.kr

82-53-620-3879

Facility Contacts

Min Sagong, MD

Role: primary

msagong@ynu.ac.kr

82-53-620-3443

Woo Jin Jung, MD

Role: primary

Jung Min Park, MD

Role: primary

Jung Yeul Kim, MD

Role: primary

Yong-Sok Ji, MD

Role: primary

Other Identifiers

YUMC2017-07-056-003

Identifier Type: -

Identifier Source: org_study_id