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

NCT03405376 | Unknown Phase 4

• 1 other identifier: YUMC2017-07-056-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

Branch Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to Week 72

Secondary Outcomes (6)

• Mean change of best corrected visual acuity

  From baseline to Week 24, 52

• mean change in central macular thickness

  From baseline to Weeks 24, 52, and 72

• mean treatment interval between injections

  From baseline to Week 72

• gain ≥ 15 letters in best corrected visual acuity

  Compared with baseline at Week 24, 52 and 72

• mean treatment interval between injections of ≥ 12 or 16 weeks

  From the last actual visit of the initiation phase to Week 72

Study Arms (1)

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)

Drug: Intravitreal aflibercept injection

Interventions

Intravitreal aflibercept injection DRUG

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

Also known as: Eylea, VEGF Trap-Eye

Branch retinal vein occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous PRP or macular laser photocoagulation in the study eye.
• 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.

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (5)

Min Sagong

Daegu, Deagu, 42415, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

RECRUITING

Maryknoll Medical Center

Busan, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

MeSH Terms

Interventions

aflibercept

Study Officials

• Min Sagong, MD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Sagong, MD

CONTACT

82-53-620-3443; msagong@ynu.ac.kr

Jinhee Kim

CONTACT

82-53-620-3879; ey001@ymc.yu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 23, 2018
• Study Start: January 25, 2018
• Primary Completion: March 31, 2019
• Study Completion: September 30, 2020
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

KR (5)