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Navilas® Clinical Results: Diabetic Macular Edema

Navilas® Clinical Results: Diabetic Macular Edema

Navilas® Clinical Results: Diabetic Macular Edema

Product catalog summary
Introduction: The document discusses the Navilas® Navigated Laser System combined with Ranibizumab for treating Diabetic Macular Edema (DME). It presents clinical results, comparing this combination therapy to Ranibizumab monotherapy.
Study Overview: A 12-month prospective study involving 66 patients with DME was conducted. Patients were divided into two groups: 34 received combination therapy (Navilas® + Ranibizumab) and 32 received Ranibizumab monotherapy.
Key Findings:
  • Visual Improvement: Both therapies showed similar improvements in visual acuity, measured by ETDRS letters gained (+8.4 for combination vs. +6.3 for monotherapy, p=0.258).
  • Injection Frequency: The combination therapy significantly reduced the number of injections needed post-loading phase (0.9 vs. 3.9, p<0.001).
  • Injection-Free Patients: 65% of patients in the combination group remained injection-free after the loading phase, compared to 16% in the monotherapy group.
Benefits of Navilas® System:
  • Higher accuracy and precision in laser treatment due to image-guided pre-positioning.
  • Reduced retreatment rates and treatment burden on patients and staff.
  • Improved patient compliance and practice efficiency.
Conclusion: The Navilas® Navigated Laser System, when combined with Ranibizumab, offers a significant reduction in treatment burden while maintaining visual outcomes, making it a promising option for managing DME.
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Catalog excerpts

Navilas® Clinical Results: Diabetic Macular Edema-1

Navilas® Clinical Results: Diabetic Macular Edema Introducing a Better Treatment Paradigm for Patients and Physicians 65 % Injection-free after loading phase Ranibizumab Monotherapy Navilas®+ Ranibizumab See study details inside. % Injection-free after loading phase

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Navilas® Clinical Results: Diabetic Macular Edema-2

Addressing Treatment Burden in Diabetic Retinopathy CAVNAV – Combination Anti-VEGF and Navigated Laser in Diabetic Macular Edema A 12-month, prospective, comparative cohort study of 66 patients with DME. Marcus Kernt, MD and colleagues, LMU Munich, Germany* Standardized combination regimen and control 3x ranibizumab Navilas®+ Ranibizumab n=34 navilas® Ranibizumab Monotherapy n=32 monthly visits for 12 months of total follow-up Results overview Ranibizumab Monotherapy Equivalent or better visual improvement (ETDRS letters gained, mean) Signficantly reduced number of injections (Post loading phase...

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Navilas® Clinical Results: Diabetic Macular Edema-3

CAVNAV combination therapy patients demonstrated stable visual gains achieved with significantly less injections after Navilas. Gains from baseline were significant in both cohorts (p<0.001), cohort differences n.s. change in etdrs letters Navilas®+ Ranibizumab Ranibizumab Monotherapy 65% of combination therapy patients remained injection-free after ranibizumab loading and Navigated Laser. 84% of monotherapy patients required retreatment. Ranibizumab Monotherapy Navilas®+ Ranibizumab

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Navilas® Clinical Results: Diabetic Macular Edema-4

US-based CAVNAV study supports similar results for Navilas + Bevacizumab combination. Change in ETDRS letters Total injections in 12 months Post loading phase injections% patients injection-free after loading phase 16% 65% 57% "Navilas® allows for a highly standardized and reproducible treatment. With image-based planning and accurate navigated execution, our diabetic patients appear to have a reduced need for re-injections in the year after Navigated laser therapy. This type of combination therapy may very well be the preferred solution for most DME patients in the future." William R. Freeman,...

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Navilas® Clinical Results: Diabetic Macular Edema-5

Entering A New Era of Retinal Disease Management Navilas® Benefits over Conventional Laser Higher Accuracy +28% Accuracy and precision through image-guided laser pre-positioning 1,2 microaneurysm/plan spot hit rate Less Retreatments - 42% Navilas® Completeness through standardized digital planning and documentation Durability, lower retreatment rate in laser monotherapy 3 Retreatments during 8 mo. follow-up “ o longer is retinal laser treatment a leap of faith. The Navilas system enables me to see N on the screen where the navigated laser will hit based on the treatment plan designed from the...

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Navilas® Clinical Results: Diabetic Macular Edema-6

Don‘t miss the Eyetube series on Navilas Navigated Laser Therapy: http://eyetube.net/ search.asp?q=navilas The Navilas® Navigated Laser System, a clinically significant advance in the management of retinal disease, reduces treatment burden on patients and staff and is also a sound investment for the practice. • N avilas® distinguishes the practice as a technology center of excellence you to efficiently meet the needs of a growing referral base while optimizing patient flow patient compliance by reducing the number of repeat injections comprehensive technology designed to effectively manage a...

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