Safety and efficacy of ziv Aflibercept compounding in refractory diabetic macular oedema

• Conditions: Diabetic macular oedema; Eye - Diseases / disorders of the eye; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000012471
• Lead Sponsor: Dr Andrew Riley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:
Ability to provide informed consent and complete study assessments
Age 18 years or older
Diabetic macular oedema not responding to compounded Avastin (Bevacizumab or ranibizumab)
Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart
Presence of sub retinal fluid or cystic intraretinal oedema on spectral domain OCT (SD-OCT) [Spectralis]
Documentation of the presence of sub retinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.

Exclusion Criteria

Pregnancy
Recent CVA or MI

Study & Design

• Study Type: Interventional
• Study Design: Not specified