Intravitreal Injections of Ziv-aflibercept for Macular Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02556723
• Date of registration: 18/09/2015
• Prospective Registration: No
• Primary sponsor: Retina Clinic, Sao Paulo, Brazil
• Public title: Intravitreal Injections of Ziv-aflibercept for Macular Diseases
• Scientific title: Intravitreal Injections of Ziv-aflibercept for Macular Diseases: Diabetic Macular Edema, Wet AMD and Macular Edema Secondary to Vein Occlusons
• Date of first enrolment: September 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02556723
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: André Maia, M.D.
• Affiliation: C.E.O.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults = 18 years with type 1 or 2 diabetes mellitus

- BCVA varying from 20/62 to 20/400 (Snellen chart) - equivalent 0.49 to 1.30 logMAR -
caused by DME

- Central Retinal Thickness on OCT (Heildelberg Engineering, Heidelberg, Germany ) of
275 mm or more

Exclusion Criteria:

- Laser photocoagulation within the previous 6 months

- Previous intraocular anti-VEGF or corticosteroid injection

- Previous systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy

- Vitreomacular traction or epiretinal membrane producing any traction on the macula on
SD-OCT scan

- Angiographic evidence of macular ischemia defined as foveal avascular zone greatest
linear dimension of more than 1000 mm or severe perifoveal capillary loss

- Previous cataract, trabeculectomy or vitrectomy

- Aphakia

- External ocular infections

- Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)

- Likelihood of needing intraocular surgery within 6 months

- Proliferative diabetic retinopathy with any evidence of retinal traction

- Systemic conditions that precluded trial enrollment included glycosylated hemoglobin
of more than 10.0%

- Past medical history of chronic renal failure requiring either dialysis or kidney
transplantation

- Blood pressure of more than 160/90 mmHg

- an arteriothrombotic event within 6 months before randomization, including myocardial
infarction, acute congestive heart failure or other cardiac event, and stroke or
transient ischemic attack

- Pregnancy or breastfeeding.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Age Related Macular Degeneration

Branch Retinal Vein Occlusion With Macular Edema

Central Retinal Vein Occlusion With Macular Edema

Diabetic Macular Edema

Intervention(s)

Drug: Intravitreal injections of ziv-aflibercept

Primary Outcome(s)

Multifocal electroretinogram responses at Week 24 and 48 [Time Frame: 24 and 48 weeks]

Secondary Outcome(s)

Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Snellen Letter Score at Week 24 and 48 [Time Frame: 24 and 48 weeks]

Change From Baseline in Central Retinal Thickness (CRT) at Week 24 and 48 as Assessed on Optical Coherence Tomography (OCT) [Time Frame: 24 and 48 weeks]

Secondary ID(s)

RetinaCLINIC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Federal University of São Paulo