Treat-and-extend Regimen of Aflibercept in Diabetic Macular Edema (VIBIM Study)

NCT02788877 | Unknown Phase 4

• 1 other identifier: 20160043
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

Efficacy of Treat-and-extend regimen (TER) using aflibercept in diabetic macular edema (DME) will be evaluated.

Conditions

Macular Edema, Diabetic

Outcome Measures

Primary Outcomes (1)

• Changes in visual acuity from baseline to 104 weeks

  Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.

  baseline and 104 weeks

Secondary Outcomes (7)

• Changes in visual acuity from baseline to 52 weeks

  baseline and 52 weeks

• Changes in CSMT from baseline to 104 weeks

  baseline and 104 weeks

• Number of injections for 52 and 104 weeks

  52 and 104 weeks

• Injection interval

  52 and 104 weeks.

• Percentage of patients with injection interval of 12 weeks or more

  104 weeks.

Study Arms (1)

treat-and-extend

EXPERIMENTAL

Aflibercept 2mg is injected into the vitreous cavity. An injection is given every 4 weeks five times and then the Treat-and-Extend process begins. If 1mm central subfield macular thickness (CSMT) improved (10% or more reduction) compared to the previous visit, the next treatment will be performed at the same interval. If CSMT is maintained (less than 10% changes), the next interval will be extended by two weeks (up to 12 weeks). If CSMT is worsened (10% or more increase), the next interval will be shortened by two weeks (minimum 4 weeks). If CSMT is stable two times at 12 weeks-interval, the injection will be deferred, and the next visit will be 8 weeks later. These process will be continued for 2 years.

Drug: aflibercept

Interventions

aflibercept DRUG

Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30 gauge needle-attached syringe.

Also known as: Eylea, VEGF Trap-Eye

treat-and-extend

Eligibility Criteria

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

You may qualify if:

• Type I or II diabetes older than 18 years old
• Patients with DME secondary to diabetes mellitus involving the center of the macula (defined as CSMT \>= 300μm measured using OCT) in the study eye.
• Decreased visual acuity to 20/40 - 20/300 to be primarily the results of DME in the study eye.
• Willing and able to comply with clinic visits and study-related procedures, and provide a signed informed consent form.

You may not qualify if:

• History of vitreoretinal surgery including scleral buckling in the study eye.
• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1.
• More than two previous macular laser treatments in the study eye.
• Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1.
• Previous treatment with anti-angiogenic drugs in the study eye within 90 days of day 1.
• Active proliferative diabetic retinopathy in the study eye.
• History of idiopathic or autoimmune uveitis in the study eye.
• Cataract surgery within 90 days before day 1 in the study eye.
• Aphakia in the study eye.
• Yttrium-aluminium-garnet capsulotomy in the study eye within 30 days before day 1.
• Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is thought to affect central vision.
• Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment in the study eye.
• Structural damage to the center of the macula in the study eye that is likely to preclude improvement in best-corrected visual acuity (BCVA) following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates.
• Evidence of infection including infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
• Uncontrolled glaucoma in the study eye (\>25mmHg) or filtration surgery and/or valve surgery for glaucoma in the past on the study eye.

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Novartis: collaborator

Study Sites (8)

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

Gospel Hospital

Busan, 602-702, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Haeundae Paik Hospital

Busan, 612-030, South Korea

Location

Busan Paik Hospital

Busan, 614-735, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Related Publications (5)

• Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):615-25. doi: 10.1016/j.ophtha.2011.01.031.

  PMID: 21459215 BACKGROUND

• Korobelnik JF, Do DV, Schmidt-Erfurth U, Boyer DS, Holz FG, Heier JS, Midena E, Kaiser PK, Terasaki H, Marcus DM, Nguyen QD, Jaffe GJ, Slakter JS, Simader C, Soo Y, Schmelter T, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Zeitz O, Metzig C, Brown DM. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014 Nov;121(11):2247-54. doi: 10.1016/j.ophtha.2014.05.006. Epub 2014 Jul 8.

  PMID: 25012934 BACKGROUND

• Gupta OP, Shienbaum G, Patel AH, Fecarotta C, Kaiser RS, Regillo CD. A treat and extend regimen using ranibizumab for neovascular age-related macular degeneration clinical and economic impact. Ophthalmology. 2010 Nov;117(11):2134-40. doi: 10.1016/j.ophtha.2010.02.032. Epub 2010 Jul 1.

  PMID: 20591490 BACKGROUND

• CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19;364(20):1897-908. doi: 10.1056/NEJMoa1102673. Epub 2011 Apr 28.

  PMID: 21526923 BACKGROUND

• Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, Jampol LM, Aiello LP, Antoszyk AN, Arnold-Bush B, Baker CW, Bressler NM, Browning DJ, Elman MJ, Ferris FL, Friedman SM, Melia M, Pieramici DJ, Sun JK, Beck RW. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015 Mar 26;372(13):1193-203. doi: 10.1056/NEJMoa1414264. Epub 2015 Feb 18.

  PMID: 25692915 BACKGROUND

MeSH Terms

Conditions

Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jae Pil Shin, MD, PhD

  Kyungbuk National University Hospital

  STUDY DIRECTOR

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: Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: April 10, 2016
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 1, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)