Mohammad Ali Sadiq1, Mohamed Kamel Soliman2, Salman Sarwar1, Aniruddha Agarwal1, Mostafa Hanout1, Sibel Demirel3, Zubir S Rentiya4, Waqar Khan5, Diana V Do1, Quan Dong Nguyen1, Yasir J Sepah6. 1. Ocular Imaging Research and Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska. 2. Ocular Imaging Research and Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska; Department of Ophthalmology, Assiut University, Assiut, Egypt. 3. Department of Ophthalmology, Ankara University, Ankara, Turkey. 4. Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland. 5. Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland; University of Maryland, Baltimore County, Baltimore, Maryland. 6. Ocular Imaging Research and Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska. Electronic address: yasir.sepah@unmc.edu.
Abstract
PURPOSE: To assess the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with diabetic macular edema (DME). DESIGN: Retrospective cohort study. PARTICIPANTS: Data from patients enrolled in the Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 with High Dose (READ-3) study were analyzed. METHODS: In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg ranibizumab. Optical coherence tomography images from patients who completed the month 6 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction were excluded from the analysis. Two independent graders graded all images. Vitreomacular adhesion was classified by size of adhesion into either focal (<1500 μm) or broad (≥1500 μm). MAIN OUTCOME MEASURES: Mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 6 and incidence of posterior vitreous detachment (PVD). RESULTS:One hundred fifty-two eyes (152 patients) were randomized in the READ-3 study. One hundred twenty-four eyes (124 patients) were eligible for the study based on study criteria. Twenty-eight eyes did not meet study criteria and were excluded from the study. At baseline, 26 patients were classified as VMA+ and 98 patients were classified as VMA-. The distribution of the 2 doses of ranibizumab (0.5 and 2.0 mg) in the 2 groups was similar. At month 6, the mean improvement in BCVA was 11.31±6.67 and 6.86±7.58 letters in the VMA+ and VMA- groups, respectively (P = 0.007). Mean improvement in CRT was -173.81±132.31 and -161.84±131.34 μm in the VMA+ and VMA- groups, respectively (P = 0.681). At month 6, among the 26 VMA+ eyes (at baseline), 7 eyes demonstrated PVD, 17 eyes showed no change in VMA status, and 2 eyes were not gradable and were excluded. CONCLUSIONS:Diabetic macular edema patients withVMA have a greater potential for improvement in visual outcomes with anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment.
RCT Entities:
PURPOSE: To assess the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with diabetic macular edema (DME). DESIGN: Retrospective cohort study. PARTICIPANTS: Data from patients enrolled in the Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 with High Dose (READ-3) study were analyzed. METHODS: In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg ranibizumab. Optical coherence tomography images from patients who completed the month 6 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction were excluded from the analysis. Two independent graders graded all images. Vitreomacular adhesion was classified by size of adhesion into either focal (<1500 μm) or broad (≥1500 μm). MAIN OUTCOME MEASURES: Mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 6 and incidence of posterior vitreous detachment (PVD). RESULTS: One hundred fifty-two eyes (152 patients) were randomized in the READ-3 study. One hundred twenty-four eyes (124 patients) were eligible for the study based on study criteria. Twenty-eight eyes did not meet study criteria and were excluded from the study. At baseline, 26 patients were classified as VMA+ and 98 patients were classified as VMA-. The distribution of the 2 doses of ranibizumab (0.5 and 2.0 mg) in the 2 groups was similar. At month 6, the mean improvement in BCVA was 11.31±6.67 and 6.86±7.58 letters in the VMA+ and VMA- groups, respectively (P = 0.007). Mean improvement in CRT was -173.81±132.31 and -161.84±131.34 μm in the VMA+ and VMA- groups, respectively (P = 0.681). At month 6, among the 26 VMA+ eyes (at baseline), 7 eyes demonstrated PVD, 17 eyes showed no change in VMA status, and 2 eyes were not gradable and were excluded. CONCLUSIONS:Diabetic macular edemapatients with VMA have a greater potential for improvement in visual outcomes with anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment.
Authors: Vincenza Bonfiglio; Robert Rejdak; Katarzyna Nowomiejska; Sandrine Anne Zweifel; Maximilian Robert Justus Wiest; Giovanni Luca Romano; Claudio Bucolo; Lucia Gozzo; Niccolò Castellino; Clara Patane; Corrado Pizzo; Michele Reibaldi; Andrea Russo; Antonio Longo; Matteo Fallico; Iacopo Macchi; Maria Vadalà; Teresio Avitabile; Ciro Costagliola; Kamil Jonak; Mario Damiano Toro Journal: Front Pharmacol Date: 2022-04-06 Impact factor: 5.988
Authors: Yun Wong; David H W Steel; Maged S Habib; Alex Stubbing-Moore; Dalvir Bajwa; Peter J Avery Journal: Graefes Arch Clin Exp Ophthalmol Date: 2016-12-12 Impact factor: 3.117