Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial
The prospective PRIME trial applied real-time, objective imaging biomarkers to determine individualized retreatment needs with intravitreal aflibercept injections (IAI) among eyes with diabetic retinopathy (DR). 40 eyes with nonproliferative or proliferative DR without diabetic macular edema receive...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-09-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/11/9/885 |
| _version_ | 1797518628205101056 |
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| author | Hannah J. Yu Justis P. Ehlers Duriye Damla Sevgi Margaret O’Connell Jamie L. Reese Sunil K. Srivastava Charles C. Wykoff |
| author_facet | Hannah J. Yu Justis P. Ehlers Duriye Damla Sevgi Margaret O’Connell Jamie L. Reese Sunil K. Srivastava Charles C. Wykoff |
| author_sort | Hannah J. Yu |
| collection | DOAJ |
| description | The prospective PRIME trial applied real-time, objective imaging biomarkers to determine individualized retreatment needs with intravitreal aflibercept injections (IAI) among eyes with diabetic retinopathy (DR). 40 eyes with nonproliferative or proliferative DR without diabetic macular edema received monthly IAI until a DR severity scale (DRSS) level improvement of ≥2 steps was achieved. Eyes were randomized 1:1 to DRSS- or PLI- guided management. At the final 2-year visit, DRSS level was stable or improved compared to baseline in all eyes, and mean PLI decreased by 11% (<i>p</i> = 0.73) and 23.6% (<i>p</i> = 0.25) in the DRSS- and PLI-guided arms. In both arms, the percent of <i>pro re nata</i> (PRN) visits requiring IAI was significantly higher in year 2 versus 1 (<i>p</i> < 0.0001). The percent of PRN visits receiving IAI during year 1 was significantly correlated with the percent of PRN visits with IAI during year 2 (<i>p</i> < 0.0001). Through week 104, 77.4% of instances of DRSS level worsening in the DRSS-guided arm were preceded by or occurred alongside an increase of PLI. Overall, consistent IAI re-treatment interval requirements were observed longitudinally among individual patients. Additionally, PLI increases appeared to precede DRSS level worsening, highlighting PLI as a valuable biomarker in the management of DR. |
| first_indexed | 2024-03-10T07:32:25Z |
| format | Article |
| id | doaj.art-eccaa24e1f394dbbb797ca6ee0c7abb9 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-10T07:32:25Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Personalized Medicine |
| spelling | doaj.art-eccaa24e1f394dbbb797ca6ee0c7abb92023-11-22T13:50:35ZengMDPI AGJournal of Personalized Medicine2075-44262021-09-0111988510.3390/jpm11090885Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME TrialHannah J. Yu0Justis P. Ehlers1Duriye Damla Sevgi2Margaret O’Connell3Jamie L. Reese4Sunil K. Srivastava5Charles C. Wykoff6Retina Consultants of Texas, Retina Consultants of America, Houston, TX 77030, USATony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195, USATony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195, USATony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195, USATony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195, USATony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195, USARetina Consultants of Texas, Retina Consultants of America, Houston, TX 77030, USAThe prospective PRIME trial applied real-time, objective imaging biomarkers to determine individualized retreatment needs with intravitreal aflibercept injections (IAI) among eyes with diabetic retinopathy (DR). 40 eyes with nonproliferative or proliferative DR without diabetic macular edema received monthly IAI until a DR severity scale (DRSS) level improvement of ≥2 steps was achieved. Eyes were randomized 1:1 to DRSS- or PLI- guided management. At the final 2-year visit, DRSS level was stable or improved compared to baseline in all eyes, and mean PLI decreased by 11% (<i>p</i> = 0.73) and 23.6% (<i>p</i> = 0.25) in the DRSS- and PLI-guided arms. In both arms, the percent of <i>pro re nata</i> (PRN) visits requiring IAI was significantly higher in year 2 versus 1 (<i>p</i> < 0.0001). The percent of PRN visits receiving IAI during year 1 was significantly correlated with the percent of PRN visits with IAI during year 2 (<i>p</i> < 0.0001). Through week 104, 77.4% of instances of DRSS level worsening in the DRSS-guided arm were preceded by or occurred alongside an increase of PLI. Overall, consistent IAI re-treatment interval requirements were observed longitudinally among individual patients. Additionally, PLI increases appeared to precede DRSS level worsening, highlighting PLI as a valuable biomarker in the management of DR.https://www.mdpi.com/2075-4426/11/9/885diabetic retinopathyanti-vascular endothelial growth factordiabetic retinopathy severity scalepanretinal leakage index |
| spellingShingle | Hannah J. Yu Justis P. Ehlers Duriye Damla Sevgi Margaret O’Connell Jamie L. Reese Sunil K. Srivastava Charles C. Wykoff Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial Journal of Personalized Medicine diabetic retinopathy anti-vascular endothelial growth factor diabetic retinopathy severity scale panretinal leakage index |
| title | Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial |
| title_full | Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial |
| title_fullStr | Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial |
| title_full_unstemmed | Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial |
| title_short | Real-Time Diabetic Retinopathy Severity Score Level versus Ultra-Widefield Leakage Index-Guided Management of Diabetic Retinopathy: Two-Year Outcomes from the Randomized PRIME Trial |
| title_sort | real time diabetic retinopathy severity score level versus ultra widefield leakage index guided management of diabetic retinopathy two year outcomes from the randomized prime trial |
| topic | diabetic retinopathy anti-vascular endothelial growth factor diabetic retinopathy severity scale panretinal leakage index |
| url | https://www.mdpi.com/2075-4426/11/9/885 |
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