Real-world management and long-term outcomes of high-risk diabetic macular edema
Main Article Content
Abstract
Purpose: Visual outcome and long-term stability of Kuwaiti diabetic patients at high risk of poor visual prognosis due to diabetic macular edema (DME), in response to early intravitreal treatment initiation and multidisciplinary management.
Methods: Longitudinal observational study of 152 eyes of 81 patients with type 2 diabetes and DME treated and monitored for 6 to 13 years.
Results: High risk of incomplete or unstable response to treatment and low final vision were associated with age over 65 years at presentation, female gender, poor metabolic control, nephropathy, baseline best-corrected visual acuity (BCVA) less than 20/40 , chronicity of the edema and atrophic changes in outer retinal layers of the macula.
Incomplete and unstable response to treatment had 80% of the eyes. Recurrences were associated with cardiac and renal complications and had severe impact on eyes with lower baseline vision .Eyes with higher baseline vision had small vision fluctuations during recurrences of the edema and recovered after treatment.
The cohort had improvement in vision after the first year of treatment, but only 25% of the eyes with lower baseline BCVA could retain it. 81% of the eyes with baseline BCVA over 20/30 maintained it for at least 6 years despite frequent recurrences.
Mean annual number of injections in the whole cohort was in the range of 1.6 ± 2.2 and was not associated with response of the edema and final BCVA.
Conclusions: Early initiation and long-term strategy of multidisciplinary management is more effective for Kuwaiti patients with high-risk diabetic maculopathy compared to observation and delay until the visual acuity deteriorates.
Keywords:
Diabetic macular edema (DME), Intravitreal treatment, Multidisciplinary management, Long-term outcomes, Visual prognosis, High-risk diabetic retinopathy, Kuwaiti patients, Best-corrected visual acuity (BCVA), Vision fluctuations, Chronic macular edema, Let me know if you'd like help refining the abstract or content further!
Article Details
How to Cite
PANDOVA, Maya G; KHUDADAH, Khaled; MITKOVA, Maya.
Real-world management and long-term outcomes of high-risk diabetic macular edema.
Medical Research Archives, [S.l.], v. 12, n. 12, dec. 2024.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/6071>. Date accessed: 06 jan. 2025.
doi: https://doi.org/10.18103/mra.v12i12.6071.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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18. Luu KY, Akhter MM, Durbin-Johnson BP, Moshiri A, Tran S, Morse LS, Park SS, Yiu G. Real-world management and long-term outcomes of diabetic macular oedema with good visual acuity. Eye (Lond). 2020 Jun;34(6):1108-1115.
19. Sacconi R, Battaglia Parodi M, Casati S, Lattanzio R, Marchini G, Bandello F. Dexamethasone Implants in Diabetic Macular Edema Patients with High Visual Acuity. Ophthalmic Res. 2017;58(3):125-130
20. Bressler SB, Odia I, Maguire MG, Dhoot DS, Glassman AR, Jampol LM, Marcus DM, Solomon SD, Sun JK; Diabetic Retinopathy Clinical Research Network. Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):382-389
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22. Iglicki M, Lavaque A, Ozimek M, Negri HP, Okada M, Chhablani J, Busch C, Loewenstein A, Zur D. Biomarkers and predictors for functional and anatomic outcomes for small gauge pars plana vitrectomy and peeling of the internal limiting membrane in naïve diabetic macular edema: The VITAL Study. PLoS One. 2018 Jul 11;13(7): e0200365.
23. Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128 (11):1580-1591.
24. AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 20 21 Feb;42(2):131-145.
2. Glassman AR, Wells JA 3rd, Josic K, Maguire MG, Antoszyk AN, Baker C, Beaulieu WT, Elman MJ, Jampol LM, Sun JK. Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study). Ophthalmology. 2020 Sep;127 (9):1201-1210
3. Ciulla TA, Bracha P, Pollack J, Williams DF. Real-world Outcomes of Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States. Ophthalmol Retina. 2018 Dec;2(12):1179-1187
4. Shimura M, Kitano S, Muramatsu D, Fukushima H, Takamura Y, Matsumoto M, Kokado M, Kogo J, Sasaki M, Morizane Y, Kotake O, Koto T, Sonoda S, Hirano T, Ishikawa H, Mitamura Y, Okamoto F, Kinoshita T, Kimura K, Sugimoto M, Yamashiro K, Suzuki Y, Hikichi T, Washio N, Sato T, Ohkoshi K, Tsujinaka H, Kusuhara S, Kondo M, Takagi H, Murata T, Sakamoto T; Japan Clinical Retina Study (J-CREST) group. Real-world management of treatment-naïve diabetic macular oedema in Japan: two-year visual outcomes with and without anti-VEGF therapy in the STREAT-DME study. Br J Ophthalmol. 2020 Sep;104(9):1209-1215.
5. Van Aken E, Favreau M, Ramboer E, Denhaerynck K, MacDonald K, Abraham I, Brié H. Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study). Clin Ophthalmol. 2020 Dec 2;14:4173-4185.
6. Holekamp NM, Campbell J, Almony A, Ingraham H, Marks S, Chandwani H, Cole AL, Kiss S. Vision Outcomes Following Anti-Vascular Endothelial Growth Factor Treatment of Diabetic Macular Edema in Clinical Practice. Am J Ophthalmol. 2018 Jul;191:83-91. Erratum in: Am J Ophthalmol. 2018 Oct;194:192.
7. Stefanickova J, Cunha-Vaz J, Ulbig M, Pearce I, Fernández-Vega Sanz A, Theodossiadis P, Kodjikian L, Izmailov A, Muston D, Vassilev Z, Lamotte B, Tückmantel C, Friedl S, Altemark A, Schwarz HJ, Katz T; POLARIS study investigators. A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS). Acta Ophthalmol. 2018 Dec;96(8):e942-e949.
8. Ziemssen F, Wachtlin J, Kuehlewein L, Gamulescu MA, Bertelmann T, Feucht N, Voegeler J, Koch M, Liakopoulos S, Schmitz-Valckenberg S, Spital G; OCEAN study group. Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany. Diabetes Ther. 2018 Dec;9(6):2271-2289.
9. Baker CW, Glassman AR, Beaulieu WT, Antoszyk AN, Browning DJ, Chalam KV, Grover S, Jampol LM, Jhaveri CD, Melia M, Stockdale CR, Martin DF, Sun JK; DRCR Retina Network. Effect of Initial Management With Aflibercept vs Laser Photocoagulation vs Observation on Vision Loss Among Patients With Diabetic Macular Edema Involving the Center of the Macula and Good Visual Acuity: A Randomized Clinical Trial. JAMA. 2019 May 21;321(19):1880-1894. doi: 10.1001/ jama.2019.5790. PMID: 31037289; PMCID: PMC6537845.
10. Bressler, S. B., Odia, I., Maguire, M. G., Dhoot, D. S., Glassman, A. R., Jampol, L. M., Marcus, D. M., Solomon, S. D., Sun, J. K., & Diabetic Retinopathy Clinical Research Network (2019). Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA ophthalmology, 137(4), 382–389. https://doi.org/10.1001/jamaophthalmol.2018.6786
11. Wong WM, Chee C, Bhargava M, Chai C, Lin H, Zhao P, Ariadarma Mangunkusumo E, Naing T, Yuen YS, Wong TY, Su X, Lingam G. Systemic Factors Associated with Treatment Response in Diabetic Macular Edema. J Ophthalmol. 2020 Mar 19;2020:1875860. doi: 10.1155/2020/1875860. PMID: 32280516; PMCID: PMC7125481.
12. Chen, YP., Wu, AL., Chuang, CC. et al. Factors influencing clinical outcomes in patients with diabetic macular edema treated with intravitreal ranibizumab: comparison between responder and non-responder cases. Sci Rep 9, 10952 (2019).
13. Zhou JJ, Koska J, Bahn G, Reaven P. Fasting Glucose Variation Predicts Microvascular Risk in ACCORD and VADT. J Clin Endocrinol Metab. 2021 Mar 25;106(4):1150-1162. doi: 10.1210/ clinem/dgaa941. PMID: 33367811; PMCID: PMC7993576.
14. American Diabetes Association; 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2021. Diabetes Care 1 January 2021; 44 (Supplement_1): S15–S33. https://doi.org/10.2337/dc21-S002
15. American Diabetes Association; 11. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2021. Diabetes Care 1 January 2021; 44 (Supplement_1): S151–S167. https://doi.org/10.2337/dc21-S011
16. Alkandari A, Alarouj M, Elkum N, Sharma P, Devarajan S, Abu-Farha M, Al-Mulla F, Tuomilehto J, Bennakhi A. Adult Diabetes and Prediabetes Prevalence in Kuwait: Data from the Cross-Sectional Kuwait Diabetes Epidemiology Program. J Clin Med. 2020 Oct 25;9(11):3420. doi: 10.3390/jcm9113420.
17. Pandova MG, Al-Merjan JI, Sadeq NA. Registered blindness in Kuwait - 15 years of dynamic changes. Ophthalmic Epidemiol. 2019 Apr;26(2):75-83
18. Luu KY, Akhter MM, Durbin-Johnson BP, Moshiri A, Tran S, Morse LS, Park SS, Yiu G. Real-world management and long-term outcomes of diabetic macular oedema with good visual acuity. Eye (Lond). 2020 Jun;34(6):1108-1115.
19. Sacconi R, Battaglia Parodi M, Casati S, Lattanzio R, Marchini G, Bandello F. Dexamethasone Implants in Diabetic Macular Edema Patients with High Visual Acuity. Ophthalmic Res. 2017;58(3):125-130
20. Bressler SB, Odia I, Maguire MG, Dhoot DS, Glassman AR, Jampol LM, Marcus DM, Solomon SD, Sun JK; Diabetic Retinopathy Clinical Research Network. Factors Associated With Visual Acuity and Central Subfield Thickness Changes When Treating Diabetic Macular Edema With Anti-Vascular Endothelial Growth Factor Therapy: An Exploratory Analysis of the Protocol T Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):382-389
21. Takamura Y, Matsumura T, Ohkoshi K, Takei T, Ishikawa K, Shimura M, Ueda T, Sugimoto M, Hirano T, Takayama K, Gozawa M, Yamada Y, Morioka M, Iwano M, Inatani M. Functional and anatomical changes in diabetic macular edema after hemodialysis initiation: One-year follow-up multicenter study. Sci Rep. 2020 May 8;10(1):7788
22. Iglicki M, Lavaque A, Ozimek M, Negri HP, Okada M, Chhablani J, Busch C, Loewenstein A, Zur D. Biomarkers and predictors for functional and anatomic outcomes for small gauge pars plana vitrectomy and peeling of the internal limiting membrane in naïve diabetic macular edema: The VITAL Study. PLoS One. 2018 Jul 11;13(7): e0200365.
23. Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128 (11):1580-1591.
24. AlQahtani AS, Hazzazi MA, Waheeb SA, Semidey VA, Semidey VA, Elgendy HK, Alkhars WI, Abouammoh MA, Al-Dhibi H. Saudi Arabia Guidelines for diabetic macular edema: A consensus of the Saudi Retina Group. Saudi Med J. 20 21 Feb;42(2):131-145.