A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)

Stefanickova, Jana; Cunha-Vaz, Josè; Ulbig, Michael W.; Pearce, Ian; Sanz, Álvaro Fernández-Vega; Theodossiadis, Panagiotis; Kodjikian, Laurent; Измайлов, А. С.; Muston, Dominic; Vassilev, Zdravko P.; Lamotte, Benedicte; Tückmantel, Claudia; Friedl, Sabine; Altemark, Andreas; Schwarz, Hans-Jörg; Katz, Todd A

doi:10.1111/aos.13771

Cited by 28 publications

(26 citation statements)

References 29 publications

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“…These numbers are also consistent with those reported for aflibercept in randomized controlled trials [22]. In routine clinical practice, the number of anti-VEGF injections is likely to be lower than the licensed posology, as shown in the POLARIS study [7], where the mean number of injections in year 1 was 4.9; however, outcomes in that study were suboptimal in comparison with other randomised controlled trials. Injection numbers were modeled to decrease [21] in years 2 and 3 to account for treat-and-extend dosing regimens [23].…”

Section: Scenario 1 (Current Pathway): Continued Treatment With Aflibsupporting

confidence: 82%

“…Anti-VEGF drugs and steroid implants have superseded thermal laser treatment as the mainstay of treatment for DME over the past decade due to the ability of these agents to stabilize and even achieve a subjective improvement in vision [6,7]. Recent studies, however, have indicated poor visual outcomes in one-third of patients after 2 years of continued anti-VEGF treatment, which may be due to a combination of factors, including a suboptimal response to the drug administered (i.e., visual and anatomic parameters indicating that a patient is not benefiting from continued treatment), suboptimal drug delivery (i.e., inadequate delivery of the drug to the eye), and poor compliance [8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

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A cost analysis comparing continued 3-year aflibercept monotherapy versus a switch from aflibercept to the fluocinolone acetonide intravitreal implant in phakic patients with chronic diabetic macular edema

Raman

2018

Expert Review of Ophthalmology

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Section: Scenario 1 (Current Pathway): Continued Treatment With Aflibsupporting

confidence: 82%

Section: Introductionmentioning

confidence: 99%

A cost analysis comparing continued 3-year aflibercept monotherapy versus a switch from aflibercept to the fluocinolone acetonide intravitreal implant in phakic patients with chronic diabetic macular edema

Raman

2018

Expert Review of Ophthalmology

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“…Several real-world studies on ranibizumab in DME have evaluated treatment patterns and outcomes over periods of 9 to 24 months. [22][23][24][25][26][27][28][29][30][31][32][33][34][35] Mean number of ranibizumab injections ranged from 3.1 to 7.2. VA gains varied between +0.0 and +8.4 letters with CRT reductions ranging from −83.9 µm to −164.6 µm.…”

Section: Discussionmentioning

confidence: 99%

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

Aken¹,

Favreau²,

Ramboer³

et al. 2020

OPTH

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Aim Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab. Methods Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5±1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis. Results The mean±SD number of treatments in the first year was 5.1±3.0 (TX-naïve), 4.5±2.7 (PRIOR-anti-VEGF) and 5.6±3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in TX-naïve (p<0.0001), by 11.8±9.9 from 61.6±8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2±10.6 from 58.2±14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of −43.8µm in TX-naïve (p=0.04), −75.7µm in PRIOR-anti-VEGF (p=0.02), and −65.8µm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment. Conclusion This real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns.

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“…Therefore, it is important to evaluate the efficacy of ranibizumab therapy in a real-world clinical setting, where not all patients receive the initial monthly injections and follow-up visits are missed. Furthermore, differences in health systems, resource availability, patient characteristics, and local practice exist among countries, as reported by several recent studies [ 17 – 19 ]. We were aiming to evaluate the outcomes achieved in the largest ophthalmology clinic in Lithuania.…”

Section: Discussionmentioning

confidence: 99%

“…Other real-world studies also reported low numbers of ranibizumab injections. There was an average of 3 to 6 injections over the first year in studies which did not exclude eyes based on the number of injections [ 17 – 19 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Treatment Patterns and Vision Outcomes with Ranibizumab for Diabetic Macular Edema

Balčiūnienė

2021

Journal of Ophthalmology

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Purpose. To assess injection patterns and vision outcomes in patients receiving intravitreal ranibizumab injections for diabetic macular edema in a real-world clinical setting. Methods. Retrospective chart review involving 74 eyes of 62 patients who started ranibizumab treatment for diabetic macular edema at the Hospital of the Lithuanian University of Health Sciences Kauno Klinikos. Data collected included follow-up visits, injections administered, and best-corrected visual acuity (BCVA). Results. Median follow-up duration was 652.5 days (min 365; max 914). Over the first year, eyes received a median of 4 injections (min 1; max 10). Among eyes with 2-year follow-up and injections during the second year, there was a median of 3 injections (min 1; max 6) over the second year. The BCVA improved by a median of 5 letters 365 ± 60 days and 730 ± 60 days after baseline. At the first visit ≥365 days after baseline, 13.5% of eyes gained ≥15 letters from baseline while 6.8% of eyes lost ≥15 letters. For 74.3% of eyes, BCVA improved (gain of ≥5 letters) or remained stable (gain/loss of ≤4 letters). Conclusion. Intravitreal ranibizumab for diabetic macular edema was effective in a real-world clinical setting, with most eyes gaining or maintaining vision. Compared with randomized prospective clinical trials, patients received less frequent injections and achieved lower vision gains.

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A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS)

Abstract: POLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.

Cited by 28 publications

References 29 publications

A cost analysis comparing continued 3-year aflibercept monotherapy versus a switch from aflibercept to the fluocinolone acetonide intravitreal implant in phakic patients with chronic diabetic macular edema

A cost analysis comparing continued 3-year aflibercept monotherapy versus a switch from aflibercept to the fluocinolone acetonide intravitreal implant in phakic patients with chronic diabetic macular edema

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

Real-World Treatment Patterns and Vision Outcomes with Ranibizumab for Diabetic Macular Edema

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