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Long-term outcomes in ranibizumab-treated patients with retinal vein occlusion; the role of progression of retinal nonperfusion.

ABSTRACT: To determine the percentage of ranibizumab-treated patients with retinal vein occlusion (RVO) who had resolution of edema for at least 6 months after the last injection, along with factors and outcomes that correlate with resolution.Post hoc analysis of open-label clinical trial.Twenty patients with branch RVO (BRVO) and 20 with central RVO (CRVO) received ranibizumab monthly for 3 months and as needed for recurrent/persistent macular edema, no more frequently than every 2 months. Patients still requiring injections after month 40 received scatter and grid laser photocoagulation to try to reduce the need for injections. Main outcome measures included the percentage of patients who had resolution of edema, change in best-corrected visual acuity (BCVA) from baseline, and change in area of retinal nonperfusion in central subfields.Nine patients with BRVO (45%) had edema resolution from injections alone after a mean of 20.2 months, 4 resolved after addition of laser, 4 were unresolved through 72 months, and 3 exited prior to resolution. Five patients with CRVO (25%) resolved from injections alone after a mean of 14.0 months, 8 remained unresolved through 72 months despite addition of laser, and 7 exited prior to resolution. For BRVO or CRVO, there was a negative correlation between posterior retinal nonperfusion area and BCVA at months 18, 24, and 36 (P < .05).In patients with RVO, infrequent ranibizumab injections to control edema may not be sufficient to prevent progression of retinal nonperfusion, which may contribute to loss of visual gains.

SUBMITTER: Sophie R

PROVIDER: S-EPMC4030598 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Long-term outcomes in ranibizumab-treated patients with retinal vein occlusion; the role of progression of retinal nonperfusion.

Sophie Raafay R Hafiz Gulnar G Scott Adrienne W AW Zimmer-Galler Ingrid I Nguyen Quan Dong QD Ying Howard H Do Diana V DV Solomon Sharon S Sodhi Akrit A Gehlbach Peter P Duh Elia E Baranano David D Campochiaro Peter A PA

American journal of ophthalmology 20131001 4

<h4>Purpose</h4>To determine the percentage of ranibizumab-treated patients with retinal vein occlusion (RVO) who had resolution of edema for at least 6 months after the last injection, along with factors and outcomes that correlate with resolution.<h4>Design</h4>Post hoc analysis of open-label clinical trial.<h4>Methods</h4>Twenty patients with branch RVO (BRVO) and 20 with central RVO (CRVO) received ranibizumab monthly for 3 months and as needed for recurrent/persistent macular edema, no more ...[more]

PMID: 24053892

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Project description:PurposeTo evaluate spectral-domain (SD)-OCT features associated with baseline vision and visual outcomes in the prospective, multicenter Study Evaluating Dosing Regimens for Treatment with Intravitreal Ranibizumab Injections in Subjects with Macular Edema following Retinal Vein Occlusion (SHORE).DesignPost hoc analysis of prospective clinical trial data.ParticipantsTwo hundred two participants in the 15-month, phase 4 SHORE study comparing monthly versus pro re nata ranibizumab after 7 monthly doses in eyes with retinal vein occlusion (RVO) with macular edema.MethodsBaseline SD-OCT images were assessed for (1) central subfield thickness (CST); (2) presence of vitreomacular adhesion, vitreomacular traction, or epiretinal membrane; (3) presence, location, and amount of intraretinal fluid or subretinal fluid (SRF); (4) presence, location, and amount of hyperreflective foci (HF); (5) disorganization of retinal inner layers (DRIL); and (6) disruption of external limiting membrane (ELM), ellipsoid zone (EZ), and interdigitation zone (IZ). Univariate and multivariate regression analyses were performed to evaluate the association of these features with baseline best-corrected visual acuity (BCVA) and change in BCVA after 7 monthly ranibizumab injections.Main outcome measuresAssociation of SD-OCT features with baseline BCVA and change in BCVA after 7 monthly ranibizumab injections.ResultsBefore therapy, worse baseline BCVA was associated with ERM presence (P = 0.0045), thicker SRF (P = 0.0006), larger intraretinal cysts (P = 0.0015), and higher percentage of DRIL (P < 0.0001), percentage of ELM disruption (P < 0.0001), percentage of EZ disruption (P = 0.0003), and percentage of IZ disruption (P = 0.0018). In multivariate models, only percentage of ELM disruption independently impacted baseline BCVA (P < 0.0001). After 7 monthly ranibizumab injections, mean BCVA improved by 18.3±12.6 Early Treatment Diabetic Retinopathy Study letters in treated eyes. The only factors independently associated with BCVA gain after 7 monthly ranibizumab treatments were younger age (P < 0.0001) and worse baseline BCVA (P < 0.0001).ConclusionsAlthough SD-OCT features may be associated with presenting vision in eyes with macular edema and RVO, most eyes treated with ranibizumab achieve substantial vision gains, and only older age and better baseline BCVA limited visual improvements.

Project description:PURPOSE:To examine the relationship between optical coherence tomography (OCT) images and clinical course in eyes with branch retinal vein occlusion (BRVO) treated with intravitreal ranibizumab injection (IVR). DESIGN:Prospective cohort study. PARTICIPANTS:Thirty eyes of 30 patients with BRVO treated with IVR. METHODS:All patients received 1 initial IVR followed by repeated injections in the pro re nata (PRN) regimen. Correlations between logarithm of minimum angle of resolution best-corrected visual acuity (logMAR BCVA) or number of IVRs after 12 months and OCT parameters including the external limiting membrane (ELM), ellipsoid zone (EZ), interdigitation zone (IZ), and photoreceptor outer segment (PROS) length at first resolution of macular edema (ME) were assessed. Resolution of ME was defined as central foveal thickness <300 ?m and the absence of subretinal fluid. OCT parameters influencing BCVA and number of IVRs were evaluated using multivariate analysis. Correlations between nonperfusion areas (NPAs) and thinning areas and changes in retinal thickness of BRVO-affected areas were assessed. RESULTS:Of the 30 patients, 27 completed this study and were included in the statistical analyses. The mean logMAR BCVA at 3, 6, and 12 months was 0.16 ± 0.19, 0.09 ± 0.20, and 0.07 ± 0.20, respectively, which improved significantly from baseline at each visit (p < 0.0001, respectively), while the mean number of IVRs at 12 months was 3.9 ± 2.2. The mean number of IVRs for the first resolution of ME was 1.6 ± 0.8. Eyes with ELM and EZ defects at the points of first resolution of ME were correlated with a significantly lower BCVA at 12 months compared with eyes with preserved ELMs and EZs (p = 0.035, p = 0.002, respectively). However, eyes with IZ defects at the points of first resolution of ME were not correlated with a significantly lower BCVA at 12 months compared with eyes with preserved IZs (p = 0.160). Defects in the EZ at the points of first resolution of ME significantly affected the number of IVRs at 12 months (p = 0.042), although the ELM and IZ did not. PROS length at the points of first resolution of ME was significantly correlated with BCVA and number of IVRs at 12 months (p = 0.006, p = 0.0008, respectively). In multivariate analysis, PROS length at the points of first resolution of ME had the most significant effect on BCVA and number of IVRs (p = 0.013, p = 0.012, respectively). NPA size on fluorescein angiography and thinning area on OCT within the macular area showed a significant correlation (p = 0.003, r = 0.971). The retinal thickness of ischemic BRVO-affected areas was significantly less than that of control areas at 10, 11, and 12 months (p = 0.001, p = 0.005, p = 0.003, respectively). CONCLUSION:We showed that the 1+PRN regimen may be a useful therapy for ME due to BRVO. In addition, PROS length at points of first resolution of ME appears to be a good indicator of BCVA and number of IVRs in BRVO patients.

Dataset Information

Long-term outcomes in ranibizumab-treated patients with retinal vein occlusion; the role of progression of retinal nonperfusion.

Publications

Long-term outcomes in ranibizumab-treated patients with retinal vein occlusion; the role of progression of retinal nonperfusion.

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