Dataset Information

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes.

ABSTRACT:

Background/objectives

DRAKO (NCT02850263) was a 24-month, prospective, non-interventional, multi-centre cohort study enrolling patients with diabetic macular oedema (DMO) including central involvement. The study evaluated UK standard-of-care intravitreal aflibercept (IVT-AFL) treatment. This analysis describes the treatment pathway and service provision for the anti-vascular endothelial growth factor (VEGF) treatment-naïve (C1) and non-naïve patients (C2) who received prior anti-VEGF treatment for DMO other than IVT-AFL.

Methods

Mean changes in best-corrected visual acuity and central subfield thickness were measured and stratified by baseline factors, including ethnicity and administration of five initial monthly injections within predefined windows. Clinic visits were classified as treatment only (T1), monitoring assessment only (T2), combined visits (T3) or post-injection visits with no treatment or assessment (T4).

Results

Median time from decision to treat to treatment was 6 days. As a percentage of total visits, T1, T2, T3 and T4 were 7%, 42%, 48% and 3% for C1 and 11%, 39%, 48% and 2% for C2. Most IVT-AFL injections were administered by healthcare professionals (HCPs) other than doctors (C1, 57.4%; C2, 58.5%). The percentage of treatments associated with a procedure-related adverse event where at least 75% of injections were completed by the same injector role were similar for doctors and other HCPs (C1, 1.1% and 0.8%; C2, 0.7%, and 1.0%).

Conclusions

Results indicate that upon DMO diagnosis, patients were treated promptly, and most visits were combined (treatment and assessment) or monitoring only. Most IVT-AFL was administered by non-physicians with a similar treatment-related safety profile as IVT-AFL administered by physicians.

SUBMITTER: Sivaprasad S

PROVIDER: S-EPMC10397211 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes.

Sivaprasad Sobha S Ghanchi Faruque F Kelly Simon P SP Kotagiri Ajay A Talks James J Scanlon Peter P McGoey Hellen H Nolan Andrew A Saddiq Moneeb M Napier Jackie J Morgan-Warren Peter P

Eye (London, England) 20230118 12

<h4>Background/objectives</h4>DRAKO (NCT02850263) was a 24-month, prospective, non-interventional, multi-centre cohort study enrolling patients with diabetic macular oedema (DMO) including central involvement. The study evaluated UK standard-of-care intravitreal aflibercept (IVT-AFL) treatment. This analysis describes the treatment pathway and service provision for the anti-vascular endothelial growth factor (VEGF) treatment-naïve (C1) and non-naïve patients (C2) who received prior anti-VEGF tre ...[more]

PMID: 36653595

Similar Datasets

Project description:BackgroundIntravitreal anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular oedema (DME) may begin with several initial monthly doses. Characteristics, treatment patterns and outcomes were compared for eyes with DME that did and did not receive such initial doses.MethodsThis was a retrospective database study using American Academy of Ophthalmology Intelligent Research in Sight® Registry data (01/01/15-31/12/20; index period). Eligible adults had documented DME within 2 months of first anti-VEGF treatment (index date), data available for 12 months beforehand, and ≥ 1 visual acuity (VA) recording ≤ 60 days before index date. Eyes must have received intravitreal anti-VEGF injections during the index period, but none in the prior 12 months. Characteristics and outcomes for eyes with initial doses (three injections within 100 days of index date) were compared with those without. Multivariate Cox Proportional Hazards modelling estimated predictors for treatment discontinuation, re-initiation, or switch; Generalized Estimating Equations-adjusted modelling estimated characteristics associated with receiving initial doses. Demographics and characteristics were summarised. Injection frequency and number, and VA were determined annually for ≤ 6 years. Discontinuations, reinitiations and switches were compared.ResultsIncluded were 217,696 eyes (n = 77,769 initial; n = 139,927 non-initial) from 166,868 patients. Mean (SD) baseline VA was numerically higher for eyes with versus without initial doses (63.0 [18.1] vs. 62.5 [19.8] letters); this remained during follow-up. Based on modelling results, Eyes with initial doses received more injections (mean [standard deviation (SD)] 11.6 [8.9] vs. 6.1 [6.8] injections) more frequently (interval 7.6 [2.8] vs. 12.6 [7.7] weeks) than eyes without. These differences occurred across follow-up years. Discontinuation (45.7% vs. 63.8%), re-initiation (17.2% vs. 25.0%), and switch (24.5% vs. 31.5%) were less common with initial doses. Asian, Black, and patients of other/unknown race were less likely (P < 0.01) to receive initial doses than White patients, as were Medicare/Medicaid-insured patients versus commercially insured patients (P < 0.01).ConclusionsVarious sociodemographic factors associate with initial anti-VEGF doses, including race, ethnicity and insurance. Although eyes with frequent initial doses maintained higher VA than those without, they also receive more injections over time. Further research may elucidate the impact of frequent initial doses versus total injection number on DME outcomes.

Dataset Information

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes.

Background/objectives

Methods

Results

Conclusions

Publications

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes.

Similar Datasets

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