Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials.

Abstract

AIMS:

To assess time to, cumulative incidence of, and functional benefit of achieving sustained ≥2-step Diabetic Retinopathy Severity Scale (DRSS) improvement in diabetic macular oedema (DMO).

METHODS:

Post hoc analysis of VISTA/VIVID including eyes with DMO treated with intravitreal aflibercept injections (IAI), 2 mg q4 weeks (2q4, n = 250) or q8 weeks after 5 monthly doses (2q8, n = 249), or laser control (n = 249). Changes from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were evaluated in sustained (≥2 consecutive visits) DRSS subgroups (≥1-step worsening, no change, ≥2-step improvement).

RESULTS:

Time to sustained ≥2-step DRSS improvement was shorter for both the IAI 2q4 and IAI 2q8 groups versus laser (both log-rank p < 0.001). Cumulative incidences of sustained ≥2-step DRSS improvement with IAI 2q4 and IAI 2q8 versus laser were 40.0% and 42.8% versus 15.5% (both p < 0.001) through week 100. Mean differences (95% CI) in BCVA gains from baseline at weeks 52 and 100 between eyes with sustained ≥2-step DRSS improvement versus sustained ≥1-step DRSS worsening were -3.0 (-8.9, 2.9) and 6.2 (0.2, 12.2) letters with laser, and 4.2 (0.8, 7.6) and 4.9 (1.3, 8.4) letters with IAI combined, respectively. Difference (95% CI) in CST reduction was significantly greater only with IAI combined at week 100 (-83.0 [-140.8, -25.3]). Correlations between BCVA and CST changes were weak.

CONCLUSIONS:

DMO eyes treated with IAI achieved sustained ≥2-step DRSS improvement significantly earlier and more frequently versus laser. This improvement was associated with greater BCVA gains, independent of CST reductions.

TRIAL REGISTRATION:

ClinicalTrials.gov ( https://clinicaltrials.gov/ ) identifiers: NCT01363440 and NCT01331681 .

• Authors: Dilsher S Dhoot, Hadi Moini, Kimberly Reed, Weiming Du, Robert Vitti, Alyson J Berliner, Rishi P Singh
• Journal: Eye (London, England) (Eye (Lond)) Vol. 37 Issue 10 Pg. 2020-2025 (07 2023) ISSN: 1476-5454 [Electronic] England
• PMID: 35440699 (Publication Type: Journal Article)
• Copyright: © 2022. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.

Chemical References

• aflibercept
• Angiogenesis Inhibitors
• Receptors, Vascular Endothelial Growth Factor
• Recombinant Fusion Proteins
• Vascular Endothelial Growth Factor A

Topics

• Humans
• Angiogenesis Inhibitors (therapeutic use)
• Diabetes Mellitus
• Diabetic Retinopathy (diagnosis, drug therapy, surgery)
• Intravitreal Injections
• Laser Coagulation (adverse effects)
• Macular Edema (diagnosis, drug therapy, surgery)
• Receptors, Vascular Endothelial Growth Factor (therapeutic use)
• Recombinant Fusion Proteins (therapeutic use)
• Tomography, Optical Coherence
• Treatment Outcome
• Vascular Endothelial Growth Factor A (therapeutic use)
• Clinical Trials as Topic