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To investigate the use of intravitreal ziv-aflibercept (IVZ) in Ghanaian patients with diabetic macular edema (DME).A retrospective study of patients with DME, who had been treated with IVZ (1.25 mg/0.05 ml), as part of routine clinical practice, on pro re nata basis between 2016 and 2018 who had a minimum follow-up of 6 months was retrieved and analyzed. The primary outcome measure was change in best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures are change in BCVA at 12 months and at the last follow-up visit, adverse events and change in central macular thickness (CMT).Twenty-five eyes of 17 patients (11 males) were included in this study. Their mean age was 60.82 ± 7.70 years and the mean duration of follow-up was 9.52 ± 3.31 months. The mean baseline BCVA (logMAR) of 0.65 ± 0.3 improved to 0.34 ± 0.16 (p 0.0001) and 0.22 ± 0.15 (p = 0.0004) at 6 and 12 months, respectively. Twelve (48%) eyes had a visual gain of at least three lines at 6 months and 4 of 12 eyes (33.3%) at 1 year. There was a significant reduction in the mean CMT at 6 and 12 months and at the last follow-up visit compared to baseline (p 0.0001). The adverse events recorded were raised intraocular pressure (four eyes) at 3, 6, and 12 months post injection, increased blood pressure in a patient with known systemic hypertension and transient memory loss in one patient.IVZ (1.25 mg) was associated with significant improvement in BCVA and reduction in CMT at 6 and 12 months in eyes with DME. A randomized clinical trial is warranted to assess this potentially cost-effective intervention for DME in low-resource settings.

Background Diabetic retinopathy is a leading cause of blindness in many countries across the world. Ghana has seen a rise in diabetic retinopathy and is working on various strategies to prevent blindness. Clinical guidelines are seen as a promising strategy for improving quality and reducing cost of care. Little is known about the processes of collaborative guideline development in the African context. Methods This case study discusses the process of developing clinical guidelines for diabetic retinopathy in Ghana via a collaboration with the Kenya team that had previously developed guidelines for Kenya. Results The main lesson learnt was the ability to overcome challenges. The main output achieved was the draft national framework, guidelines and training slides on the guidelines. Conclusion Horizontal international collaboration can aid development of clinical guidelines.

Aim To report the short-term outcomes of eyes with choroidal neovascularisation (CNV) associated with causes other than age-related macular degeneration (AMD) after treatment with intravitreal ziv-aflibercept (IVZ) injections. Methods This retrospective study included eyes with non-AMD-related CNV that were treated with IVZ (1.25 mg/0.05 mL) on a pro re nata basis. The primary outcome measure is the mean change in best-corrected visual acuity (BCVA) and secondary outcome measures include the mean change in central macular thickness (CMT) and adverse events. Results 23 eyes of 19 patients with CNV due to high myopia (9), macular telangiectasia (4), central serous chorioretinopathy (3), choroidal osteoma (2), choroiditis (2), Best9s disease (2) and idiopathic (1) were treated. The mean follow-up period was 4±1.9 months. The median number of IVZ injections was 1 (range, 1–3) and the median treatment-free interval at the time of the final visit was 3 months (range, 1–8). The mean BCVA improved from 0.67 LogMAR to 0.58 LogMAR (p=0.0507). Nine of 23 (39%) eyes had BCVA gains of at least 0.1 LogMAR, 11 (48%) eyes had stable BCVA (within 0.1 LogMAR of baseline) and 3 (13%) eyes had a BCVA decline of at least 0.1 LogMAR at the final visit. The mean CMT improved significantly from baseline until the final visit (22 vs 174.5 μm; p=0.037). No ocular or systemic adverse events were noted. Conclusions IVZ improves CMT in patients with CNV associated with causes other than AMD, but improvements in BCVA are modest.

Brief Background: Retinal vascular diseases are a significant cause of visual loss world-wide, including Ghana. Anti-vascular endothelial growth factor (anti-VEGF) such as aflibercept, ranibizumab and bevacizumab have become the standard of care for diabetic macular edema (DME), macular edema (ME) following retinal vein occlusions (RVO), and neovascular age related macular degeneration(nvAMD). Aflibercept has been approved by the United States of America (USA) Food and Drug Administration (FDA) for the treatment of DME, nvAMD, and ME following RVO. The recommended dose of intravitreal aflibercept is 2mg in 0.05ml administered monthly or initial monthly injections for the first 3 months followed by 2 monthly injections. Aflibercept is highly expensive (USD1850 per dose) and not available in many developing countries including Ghana. Ziv-aflibercept, a molecule structurally identical to aflibercept but differs due to its formulation with hyper-osmolality has been approved by the USA FDA for the treatment of metastatic colorectal cancers. Ziv-aflibercept, used off-label, has been found to be safe in patients with DME and nvAMD in phase 1 trials at a dose of 1.25mg in 0.05ml. The cost of compounded ziv-aflibercept is much reduced to USD 67 per dose. The 1.25mg dose of ziv-aflibercept is below that recommended for intravitreal injections of aflibercept. However, to the best of our knowledge, there are no data available on the safety of 2mg of ziv-aflibercept, although in vitro studies indicate that it is safe. Furthermore, there is no data on the intravitreal administration of ziv-aflibercept in the Ghanaian population to date. Aim: To evaluate the safety of 1.25mg and 2mg ziv-aflibercept in Ghanaian population with retinal vascular diseases. Methodology: This is a prospective, randomised, double masked, phase 1, interventional study. Twenty (20) patients with centre involving DME, ME following RVO, and nvAMD will be assigned to 2 groups: 1.25mg/0.05ml (control) and 2mg/0.08ml ziv- aflibercept and will receive 3 doses of ziv-aflibercept at 4 weekly intervals. Intraocular pressure will be determined 30 minutes following injection and in subsequent visits. Safety data will be collected at days 1and 7 after initiation of treatment, and at 4, 8 and 12 weeks. Primary outcome measures are ocular safety parameters- including the incidence of pain, blurred vision, raised intraocular pressure, intraocular inflammation and endophthalmitis(eye infection), as well as systemic safety at 4 weeks. Secondary outcome measures are ocular and systemic safety parameters at 12 weeks, change in BCVA (ETDRS letters), central subfield foveal thickness (CSFT) and central retinal thickness (CRT) as measured on optical coherent tomography (OCT) at 4 and 12 weeks. Expected Outcome: We seek to evaluate the safety of 2 different doses of ziv-aflibercept in patients with DME, ME following RVO and nvAMD in a Ghanaian population. We expect that there will be no differences in safety between the 2 doses of ziv-aflibercept.