Intravitreal Bevacizumab for the Treatment of Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy.
ABSTRACT: PURPOSE:To evaluate the outcomes of intravitreal bevacizumab (IVB) use in patients with a vitreous hemorrhage (VH) secondary to proliferative diabetic retinopathy (PDR). DESIGN:Retrospective, interventional case series. METHODS:Patients who presented to Scheie Eye Institute between January 2008 and January 2015 with a new VH secondary to PDR and treated with IVB were included. Exclusion criteria consisted of IVB treatment prior to the study, a history of pars plana vitrectomy (PPV), and less than 1 year of follow-up. Outcomes of interest were additional treatments including PPV, injections, and panretinal photocoagulation (PRP), as well as visual acuity at baseline and at 1 year. RESULTS:Of the 111 eligible eyes, 55 (49.5%) had PRP, 35 (31.6%) were managed with injections alone, and 21 (18.9%) had PPV after 1 year. The overall average number of injections during this time was 2 (range, 1-9), and 13 (11.7%) eyes were managed with a single injection alone. Of the 69 eyes with 2 years of follow-up, 43 (62.3%) had PRP, 16 (23.2%) were treated with injections alone, and 10 (14.5%) had PPV. CONCLUSIONS:This study underscores the potentially important role that IVB injections have in the management of patients with VH secondary to PDR. The results indicate that a proportion of patients may be treated with a minimal amount of intervention requiring 1 or 2 anti-vascular endothelial growth factor injections only. Also, the rate of PPV at 2 years (27.9%, n = 31) suggests that most patients may be managed nonsurgically.
Project description:To evaluate the efficacy and safety of intravitreal bevacizumab (IVB) injections for the treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).Prospective study of consecutive PDR with prior complete PRP patients, who presented with new dense VH, were treated with IVB injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, and 12 weeks and 6, 9, and 12 months after the first injection. Reinjection was done in non-clearing and recurrent VH.Eighteen eyes of 18 patients, mean age 47.7 ± 12.69 years were included. In all, 14 (77.78%) patients had type 2 diabetes mellitus. Systemic hypertension and dyslipidemia were the most common systemic diseases. All cases were phakic eye with previous complete PRP. Patients received 1.6 ± 0.42 intravitreal injections over a 12-month period. VH cleared completely in 7 (38.89%), 9 (50%), and 13 (72.22%) eyes after 6 weeks, 6 months, and 12 months, respectively. Re-bleeding, however, occurred in 10 (56%) eyes during the follow-up period, and 5 (28%) eyes still had residual VH at the last visit. Statistically significant visual gain was observed in 9 (50%) eyes. Unfortunately, 2 (11%) eyes had severe visual loss because of the tractional retinal detachment (TRD). Mild ocular complication was detected in one patient.IVB injection had good efficacy and safety for treatment of new VH in patients with PDR and prior complete PRP. This procedure may be especially relevant for diabetic patients at high-risk for surgical intervention.
Project description:Background:To evaluate the safety and efficacy of intravitreal ziv-aflibercept (IVZ) in the management of vitreous hemorrhage (VH) in eyes with previously lasered proliferative diabetic retinopathy (PDR). Methods:In a prospective multicenter study, previously lasered eyes who had dense VH from PDR underwent intravitreal injection of ziv-aflibercept (IVZ) (1.25 mg aflibercept). Demographic characteristics of the patients, baseline and final logMar visual acuity, number of injections, VH clearance time, and need for vitrectomy were recorded. Results:Twenty-seven eyes of 21 patients were included in the study. Mean age of study patients was 61.3?±?14.1 years with mean duration of diabetes mellitus of 22.6?±?7.8 years. Mean logMAR BCVA at baseline was 1.41?±?1.26 (Snellen equivalent 20/514) and at the last visit 0.55?±?0.61 (Snellen equivalent 20/70) with a mean gain of 0.86 EDTRS line (paired student t test?=?5.1; p???0.001). Mean number of IVZ 2.4?±?1.6 (range 1-6). The mean follow-up time was 11.7?±?11.1 months (range 1-34). Mean time for visual recovery and/or VH clearance was 5.7?±?3.3 weeks. Eyes, which required multiple injections, the interval period between injections for recurrent VH was 6.4?±?5.2 months. No subject required vitrectomy. No ocular or systemic adverse effects were noted. Conclusions:IVZ injections had good short-term safety and efficacy for the therapy of new or recurrent VH in previously lasered eyes with PDR reducing somewhat the need for vitrectomy.Trial registration: NCT02486484.
Project description:Importance:Ranibizumab is a viable treatment option for eyes with proliferative diabetic retinopathy (PDR) through 2 years. However, longer-term results are needed. Objective:To evaluate efficacy and safety of 0.5-mg intravitreous ranibizumab vs panretinal photocoagulation (PRP) over 5 years for PDR. Design, Setting, and Participants:Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial evaluated 394 study eyes with PDR enrolled February through December 2012. Analysis began in January 2018. Interventions:Eyes were randomly assigned to receive intravitreous ranibizumab (n?=?191) or PRP (n?=?203). Frequency of ranibizumab was based on a protocol-specified retreatment algorithm. Diabetic macular edema could be managed with ranibizumab in either group. Main Outcomes and Measures:Mean change in visual acuity (intention-to-treat analysis) was the main outcome. Secondary outcomes included peripheral visual field loss, development of vision-impairing diabetic macular edema, and ocular and systemic safety. Results:The 5-year visit was completed by 184 of 277 participants (66% excluding deaths). Of 305 enrolled participants, the mean (SD) age was 52 (12) years, 135 (44%) were women, and 160 (52%) were white. For the ranibizumab and PRP groups, the mean (SD) number of injections over 5 years was 19.2?(10.9) and 5.4?(7.9), respectively; the mean (SD) change in visual acuity letter score was 3.1?(14.3) and 3.0?(10.5) letters, respectively (adjusted difference,?0.6; 95% CI, -2.3 to 3.5; P?=?.68); the mean visual acuity was 20/25 (approximate?Snellen equivalent) in both groups at 5 years. The mean (SD) change in cumulative visual field total point score was -330?(645) vs -527?(635) dB in the ranibizumab (n?=?41) and PRP (n?=?38) groups, respectively (adjusted difference,?208 dB; 95% CI, 9-408). Vision-impairing diabetic macular edema developed in 27 and 53 eyes in the ranibizumab and PRP groups, respectively (cumulative probabilities: 22% vs 38%; hazard ratio,?0.4; 95% CI, 0.3-0.7). No statistically significant differences between groups in major systemic adverse event rates were identified. Conclusions and Relevance:Although loss to follow-up was relatively high, visual acuity in most study eyes that completed follow-up was very good at 5 years and was similar in both groups. Severe vision loss or serious PDR complications were uncommon with PRP or ranibizumab; however, the ranibizumab group had lower rates of developing vision-impairing diabetic macular edema and less visual field loss. Patient-specific factors, including anticipated visit compliance, cost, and frequency of visits, should be considered when choosing treatment for patients with PDR. These findings support either anti-vascular endothelial growth factor therapy or PRP as viable treatments for patients with PDR. Trial Registration:ClinicalTrials.gov Identifier: NCT01489189.
Project description:PURPOSE:To compare rates and identify predictive factors for events that represent worsening of proliferative diabetic retinopathy (PDR) in eyes treated with panretinal photocoagulation (PRP) or ranibizumab. DESIGN:Randomized clinical trial (55 United States sites). PARTICIPANTS:Three hundred ninety-four study eyes from 305 adults with PDR, visual acuity (VA) 20/320 or better, and no history of PRP. INTERVENTION:Panretinal photocoagulation or intravitreous ranibizumab injections (0.5 mg/0.05 ml). MAIN OUTCOME MEASURES:Time from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma. RESULTS:Through 2 years, the cumulative probability of worsening PDR was 42% (PRP) versus 34% (ranibizumab; hazard ratio [HR], 1.33; 99% confidence interval [CI], 0.90 to 1.98; P = 0.063). Worse baseline levels of diabetic retinopathy severity (Early Treatment Diabetic Retinopathy Study scale) were associated with increased risk of worsening PDR, regardless of treatment group (64% [high-risk PDR or worse] vs. 23% [moderate PDR or better]; HR, 3.97; 99% CI, 2.48 to 6.36; P < 0.001). In the PRP group, eyes receiving pattern scan versus conventional single-spot PRP also were at higher risk for worsening PDR (60% vs. 39%; HR, 2.04; 99% CI, 1.02 to 4.08; P = 0.008), regardless of the number of spots placed or the number of sittings to complete the initial PRP. Eyes in both groups with vision-impairing (VA 20/32 or worse) center-involved diabetic macular edema (DME) at baseline were required to receive ranibizumab for center-involved DME. Therefore the composite outcome was compared by treatment in the subgroup of eyes that did not have vision-impairing center-involved DME at baseline. For these eyes, the rate of PDR-worsening was greater with PRP than ranibizumab (45% vs. 31%; HR, 1.62; 99% CI, 1.01 to 2.60; P = 0.008). CONCLUSIONS:In eyes with PDR, ranibizumab resulted in less PDR worsening compared with PRP, especially in eyes not required to receive ranibizumab for center-involved DME. Although anti-vascular endothelial growth factor therapy requires a more frequent visit schedule than PRP, these findings provide additional evidence supporting the use of ranibizumab as an alternative therapy to PRP for PDR, at least through 2 years.
Project description:PURPOSE: To evaluate the long-term visual outcomes of pars plana vitrectomy (PPV) for polypoidal choroidal vasculopathy (PCV)-associated vitreous haemorrhage (VH). METHOD: We retrospectively reviewed the records of patients with PCV-related VH who underwent PPV. The main outcome measures were best-corrected visual acuity (BCVA) and fundus findings at 3 months postoperatively and final visit. RESULTS: Seventeen eyes of 17 patients with massive subretinal haemorrhage (16.7±7.1 disc size of mean subretinal haemorrhage area) were enrolled. The mean postoperative follow-up period was 25.2 months. Four eyes received intravitreal bevacizumab injections, and three eyes underwent photodynamic therapy before the onset of VH. The mean BCVA improved from logarithm of the minimum angle of resolution (LogMAR) of 2.63±0.57 preoperatively to 1.43±0.82 at final visit (P<0.001). Among the eyes with initial polyps at subfoveal or juxtafoveal area, 16.70% achieved final BCVA ≥20/400 (LogMAR 1.3), whereas 87.50% of eyes with initial polyps at extrafoveal area had final BCVA ≥20/400 (Fisher's exact test, P=0.026). CONCLUSIONS: PCV with massive subretinal haemorrhage is at risk for breakthrough VH. The visual prognosis in eyes with PCV-related breakthrough VH is variable after vitrectomy. Initial polyps at the extrafoveal area led to better functional outcomes. Early vitrectomy may be beneficial for visual recovery after PCV-related VH.
Project description:PURPOSE: The purpose of this study is to evaluate the efficacy of preoperative intravitreal bevacizumab (IVB) for improving outcomes in vitrectomy for diabetic retinopathy-related non-clearing vitreous haemorrhage and/or tractional retinal detachment. METHODS: Medical record from patients undergoing vitrectomy for proliferative diabetic retinopathy (PDR) were retrospectively analysed (2003-2011). From 2007, IVB (1.25 mg 2-4 days before operating) was used on all eyes. Eyes receiving IVB were compared with those that did not receive IVB. Intraoperative complications, reoperation rates, and final visual acuity were the core outcome measures. RESULTS: Data were analysed for 88 patients (101 eyes). In all, 41 (41%) patients had received IVB, whereas 60 (59%) patients had not. Significant intraoperative haemorrhage occurred in six eyes (10%) in the non-IVB group and in one (2.4%) IVB eyes (P=0.24). Silicon oil was used in 29 (48%) non-IVB eyes and in 11 (27%) IVB eyes (P=0.03). The non-IVB eyes underwent significantly more vitreoretinal reoperations (P=0.01) and were significantly more likely to lose two or more lines of vision at the final follow-up (P=0.03). The numbers needed to treat (NNT) blindness (<3/60) was four for non-IVB eyes and two for the IVB group. CONCLUSIONS: IVB reduces surgical complications, the use of silicon oil, and the need for further retinal surgery. The NNT to restore useful vision (≥3/60) to a blind eye were significantly lower in the IVB group. Vitreoretinal surgery for the complications of PDR is effective in an East African context, and IVB should be considered a valuable adjunct.
Project description:Importance:The DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy (PDR) treated with ranibizumab is not worse at 5 years than that of eyes treated with panretinal photocoagulation (PRP). Moreover, the ranibizumab group had fewer new cases of diabetic macular edema (DME) with vision loss or vitrectomy but had 4 times the number of injections and 3 times the number of visits. Although 2-year cost-effectiveness results of Protocol S were previously identified, incorporating 5-year data from Protocol S could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system. Objective:To evaluate 5- and 10-year cost-effectiveness of therapy with ranibizumab, 0.5 mg, compared with PRP for treating PDR. Design, Setting, and Participants:A preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety, and resource utilization data through 5 years of follow-up for 213 adults diagnosed with PDR and simulating results through 10 years. Interventions:Intravitreous ranibizumab, 0.5 mg, at baseline and as frequently as every 4 weeks based on a structured retreatment protocol vs PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss. Main Outcomes and Measures:Incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP were evaluated for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent, 20/32 or worse) at baseline. Results:The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white. The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582 268 per quality-adjusted life-year (QALY) at 5 years and $742 202/QALY at 10 years. For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years. Conclusions and Relevance:This study suggests that during 5 to 10 years of treatment, ranibizumab, 0.5 mg, as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for eyes presenting with PDR and vision-impairing CI-DME, but not for those with PDR but without vision-impairing CI-DME. Substantial reductions in anti-vascular endothelial growth factor cost may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME. Trial Registration:ClinicalTrials.gov identifier: NCT01489189.
Project description:To compare efficacy and safety of intravitreal aflibercept (IVA) injection with panretinal photocoagulation (PRP) versus early vitrectomy for diabetic vitreous hemorrhage (VH). Prospective, randomized study that included 34 eyes with diabetic VH. They were divided into two groups, Group ? (17 eyes) received three successive IVA injections followed by PRP and group ?? (17 eyes) for whom early vitrectomy was done. Follow up was carried out after one, two, three, six and nine months. The primary outcome measure was change in the mean best corrected visual acuity (BCVA) after nine months, secondary outcome measures were mean duration of clearance of VH and rate of recurrent hemorrhage with any additional treatment in both groups. Complications were reported. There was no statistically significant difference regarding initial demographic criteria between both groups. The mean final log MAR BCVA was statistically better than the initial BCVA in both groups (0.51?±?0.20, 1.17?±?0.48 for group I and 0.48?±?0.18, 1.44?±?0.44 for group II, P <?0.001). There was no statistically significant difference between both groups regarding the mean final Log Mar BCVA (0.51?±?0.20 for group I, 0.48?±?0.18 for group II, p ??0.05), the mean duration of clearance of VH was 7.8?±?1.8?weeks, 5?days for group I and II respectively. PRP was completely done for all eyes in group I after three months. The difference in the recurrence rate between group I (29.4%) and group II (11.8%) was statistically significant (p <?0.05). Vitrectomy was done for three eyes (17.6%) due to recurrent non-resolving VH in group I. late recurrent VH occurred in two eyes (11.8%) in group II, IVA was given with complete clearance of the hemorrhage. No vision threatening complications were reported in both groups. Both intravitreal injection of aflibercept followed by PRP and early vitrectomy are effective and safe modalities for treatment of diabetic vitreous hemorrhage. Early vitrectomy leads to faster vision gain with less incidence of recurrence than intravitreal injection. Randomized clinical trial under the number of NCT04153253 on November 6, 2019 "Retrospectively registered".
Project description:To investigate the changes in choroidal thickness (ChT) following panretinal photocoagulation (PRP) for diabetic retinopathy (DR) and compare ChT in relation to DR severity.Thirty-two eyes [19 eyes with proliferative DR (PDR) and 13 eyes with severe nonproliferative DR (NPDR)] for which PRP was necessary were analyzed. ChT was measured before PRP and at 1, 3, and 6 months after PRP using the swept-source optical coherence tomography. ChT of the 61 eyes matched with the PDR patients for the mean age and axial length was also measured and statistically compared in relation to severity.The central field ChT before PRP treatment was 268.6 ± 104.5 µm (mean ± standard deviation) and was significantly decreased at 1, 3, and 6 months after PRP (254.5 ± 105.3, 254.2 ± 108.2, and 248.1 ± 101.8 µm, respectively, P < 0.0001). The central field ChT of severe NPDR (323.2 ± 61.3 µm) was significantly thicker than that of normal (248.3 ± 70.7 µm) and mild to moderate NPDR (230.0 ± 70.3 µm, P = 0.0455 and 0.0099, respectively). Moreover, the central field ChT of PDR (307.3 ± 84.1 µm) was significantly thicker than of mild to moderate NPDR (P = 0.0169).ChT significantly decreased after PRP, which continued for at least 6 months after treatment. ChT of severe NPDR and PDR was significantly thicker than that of mild to moderate NPDR. ChT of patients with DR was changed according to the treatment and severity of DR.
Project description:Importance:The Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular edema (DME). However, ranibizumab injections are costly. Thus, it would be useful to examine the relative cost-effectiveness of these 2 treatment modalities. Objective:To evaluate incremental cost-effectiveness ratios of 0.5-mg ranibizumab therapy vs PRP for PDR. Design, Setting, and Participants:Preplanned secondary analysis using efficacy, safety, and resource utilization data through 2 years of follow-up at 55 US sites for 213 adults with PDR. Data were collected from February 2012 to January 2015. Interventions:Intravitreous 0.5-mg ranibizumab at baseline and as frequently as every 4 weeks based on a structured retreatment protocol or PRP at baseline for PDR. Eyes in both groups could receive ranibizumab for concomitant DME. Main Outcomes and Measures:Incremental cost-effectiveness ratios of ranibizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline vision-impairing (Snellen equivalent 20/32 or worse) DME and without baseline vision-impairing DME. Results:The study included 305 adults with PDR, the mean age was 52 years, 44% were women, and 52% were white. Of the 46 participants with PDR and vision-impairing DME at baseline, 21 were assigned to the ranibizumab group and 25 to the PRP group (plus ranibizumab for DME). Among the remaining participants without baseline vision-impairing DME, 80 and 87 were in the ranibizumab and PRP groups, respectively. For participants with and without baseline vision-impairing DME, the incremental cost-effectiveness ratios of ranibizumab therapy compared with PRP were $55?568/quality-adjusted life-year and $662?978/quality-adjusted life-year, respectively, over 2 years. Conclusions and Relevance:Over 2 years, compared with PRP, 0.5-mg ranibizumab as given in this trial is within the $50?000/quality-adjusted life-year to $150?000/quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME. Trial Registration:Clinicaltrials.gov Identifier: NCT01489189.