Safety of ziv-aflibercept in retinal diseases in a Ghanaian population.

Not Applicable

• Conditions: Eye Diseases; diabetic macula edema,

• Registration Number: PACTR201701001940111
• Lead Sponsor: Imoro Zeba braimah

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-25
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 18 years or older
Meets diagnostic criteria for DM, RVO and active nvAMD (Appendix I)
Treatment naïve
Understands and willing to sign consent form
Able to comply with clinic visits
Centre involving ME in patients with diabetes mellitus and RVO with retinal thickness >300um using SD- OCT
BCVA of 6/12 or worse

Exclusion Criteria

Glaucoma or raised intraocular pressure (>21mmHg)
Intraocular surgery within 3 months in the study eye
History of uveitis
Pregnant or breastfeeding mother
Renal failure on dialysis or had kidney transplant
Allergy to active drug or excipients
Cardiovascular events such as myocardial infarction or CVA
Eye infections such blepharitis, dacryocystitis, conjunctivitis or keratitis.
Unwilling to sign consent form or to come for follow up visits
Myopia ¿-6.0 Dioptres

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety of intravitreal ziv-aflibercept includingincidence of raised intraocular pressure, cataract progression, intraocular inflammation and endophthalmitis

Secondary Outcome Measures

Name	Time	Method
ocular and systemic safety parameters, change in BCVA (ETDRS letters), central subfield foveal thickness (CSFT) and central retinal thickness (CRT) using SD-OCT