Dataset Information

Peripheral capillary non-perfusion in treatment-naive proliferative diabetic retinopathy associates with postoperative disease activity 6 months after panretinal photocoagulation.

ABSTRACT: BACKGROUND/AIMS:With the perspective to provide individualised panretinal laser photocoagulation (PRP) for proliferative diabetic retinopathy (PDR), we evaluated if retinal peripheral capillary non-perfusion (PCNP) and oximetry, as non-invasive markers of retinal metabolism and function, could predict disease activity 6?months after PRP. METHODS:We performed a prospective, interventional study of patients with treatment-naïve PDR. Retinal oximetry and ultra-widefield fluorescein angiography were performed at baseline (BL) and three (3M) and 6?months (6M) after PRP by a navigated laser system. At 6M follow-up, patients were divided according to disease activity: active or inactive. RESULTS:We included 33 eyes, and 69.6% were men. At BL, the median age and duration of diabetes (with IQRs) were 51.6±23.4?and 20.0±15.0 years. Haemoglobin A1c was 63.0±17.0?mmol/mol and blood pressure was 152±37/82±24?mm Hg. At BL and M6, patients with postoperative disease activity (30.3.%, n=10) had a larger area with PCNP than those with inactive PDR (BL: 51%-75% vs 26%-50%, p=0.03; 6M: 51%-75% vs 26%-50%, p=0.03). The area of PCNP did not change from BL to 6M in either group (inactive PDR: p=0.38, active PDR: p=0.87). Changes in retinal oxygen saturation were not found to be clinical relevant. CONCLUSION:We found the area of PCNP at all timepoints to be statistically larger in patients with active PDR 6?months after PRP treatment. Therefore, the area of PCNP, at baseline, may serve as a potential predictive marker for PDR activity after treatment.

SUBMITTER: Torp TL

PROVIDER: S-EPMC6582729 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Peripheral capillary non-perfusion in treatment-naïve proliferative diabetic retinopathy associates with postoperative disease activity 6 months after panretinal photocoagulation.

Torp Thomas Lee TL Kawasaki Ryo R Wong Tien Yin TY Peto Tunde T Grauslund Jakob J

The British journal of ophthalmology 20180801 6

<h4>Background/aims</h4>With the perspective to provide individualised panretinal laser photocoagulation (PRP) for proliferative diabetic retinopathy (PDR), we evaluated if retinal peripheral capillary non-perfusion (PCNP) and oximetry, as non-invasive markers of retinal metabolism and function, could predict disease activity 6 months after PRP.<h4>Methods</h4>We performed a prospective, interventional study of patients with treatment-naïve PDR. Retinal oximetry and ultra-widefield fluorescein a ...[more]

PMID: 30068515

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Project description:IMPORTANCE:Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME). OBJECTIVE:To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015. INTERVENTIONS:Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n?=?203 eyes), or ranibizumab, 0.5 mg, by intravitreous injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n?=?191 eyes). Eyes in both treatment groups could receive ranibizumab for DME. MAIN OUTCOMES AND MEASURES:The primary outcome was mean visual acuity change at 2 years (5-letter noninferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization. RESULTS:Mean visual acuity letter improvement at 2 years was +2.8 in the ranibizumab group vs +0.2 in the PRP group (difference, +2.2; 95% CI, -0.5 to +5.0; P?<?.001 for noninferiority). The mean treatment group difference in visual acuity area under the curve over 2 years was +4.2 (95% CI, +3.0 to +5.4; P?<?.001). Mean peripheral visual field sensitivity loss was worse (-23 dB vs -422 dB; difference, 372 dB; 95% CI, 213-531 dB; P?<?.001), vitrectomy was more frequent (15% vs 4%; difference, 9%; 95% CI, 4%-15%; P?<?.001), and DME development was more frequent (28% vs 9%; difference, 19%; 95% CI, 10%-28%; P?<?.001) in the PRP group vs the ranibizumab group, respectively. Eyes without active or regressed neovascularization at 2 years were not significantly different (35% in the ranibizumab group vs 30% in the PRP group; difference, 3%; 95% CI, -7% to 12%; P?=?.58). One eye in the ranibizumab group developed endophthalmitis. No significant differences between groups in rates of major cardiovascular events were identified. CONCLUSIONS AND RELEVANCE:Among eyes with proliferative diabetic retinopathy, treatment with ranibizumab resulted in visual acuity that was noninferior to (not worse than) PRP treatment at 2 years. Although longer-term follow-up is needed, ranibizumab may be a reasonable treatment alternative, at least through 2 years, for patients with proliferative diabetic retinopathy. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01489189.

Project description:IntroductionDiabetic retinopathy (DR) is microangiopathy causing ischemia leading to proliferative diabetic retinopathy and macular edema. Panretinal photocoagulation (PRP) reverses the ischemia leading to regression of neovessels. Most previous studies showed the large vessel effects of PRP, while optical coherence tomography angiography (OCTA) allowed noninvasive quantification of microvascular retinal changes.AimTo study the effect of PRP on microvascular retinal vessels in a detailed manner at different retinal and choroidal levels using OCTA.Patients and methodsThis study was a prospective interventional study. 30 eyes of 18 diabetic patients with PDR were included. All patients were evaluated clinically and with OCTA (Avanti RTVue-XR system, Optovue) to evaluate superficial and deep vessels density (VDs), choroidal flow, and FAZ area before PRP (base line) and 1 month and 6 months after PRP.ResultsPRP improved vessels density at superficial (SCP), deep (DCP), and choriocapillaris levels. Foveal vessel density at SCP and DCP were statistically significantly increased. SCP was 28.76 ± 2.56 at base line and was increased to 29.84 ± 2.47 and 30.89 ± 2.20 after 1 month and after 6 months, respectively. DCP was 34.08 ± 5.59 at base line and was increased to 34.93 ± 5.66 and 36.09 ± 5.62 after 1 month and after 6 months, respectively. Foveal choriocapillaris was statistically significantly increased from 63.04 ± 2.66 at base line to 63.48 ± 2.65 and 63.98 ± 2.78 after 1 month and 6 months, respectively. Choroidal flow was increased from 1.74 ± 0.07 at base line to 1.75 ± 0.09 at 1 month which was nonsignificant (P = 0.72), but it was significantly increased to 1.87 ± 0.27 6 months after PRP (P = 0.009). FAZ area was significantly improved after PRP. FAZ area was decreased from 0.56 ± 0.27 at base line to 0.50 ± 0.21 after 1 month and to 0.46 ± 0.21 after 6 months.ConclusionOCTA parameters were significantly improved by PRP in PDR patients, possibly due to redistribution of blood in occluded capillary plexuses.Trials registryNCT04976361.

Project description:PurposeTo identify baseline factors associated with change in visual acuity or development of vision-impairing central-involved diabetic macular edema (DME) over 2 years when treating proliferative diabetic retinopathy (PDR) with ranibizumab or panretinal photocoagulation (PRP).DesignPost hoc analyses of randomized, multicenter clinical trial data.ParticipantsEyes completing the 2-year visit (n = 328) or without vision-impairing central-involved DME at baseline (n = 302) in Diabetic Retinopathy Clinical Research Network Protocol S.MethodsIntravitreous ranibizumab (0.5 mg/0.05 ml) or PRP.Main outcome measuresChange in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years.ResultsAfter multivariable model selection with adjustment for baseline visual acuity and central subfield thickness, no factors were identified as associated with change in visual acuity or development of vision-impairing central-involved DME within the ranibizumab group. In the PRP group, worse change in visual acuity was more likely with higher hemoglobin A1c level (-0.6 letters per 1% increase; 95% confidence interval [CI], -1.2 to -0.1 letters; continuous P = 0.03), more severe diabetic retinopathy (difference between high-risk PDR or worse vs. moderate PDR or better, -2.8 letters [95% CI, -5.5 to -0.2 letters]; continuous P = 0.003), and higher mean arterial pressure (difference between ≥100 mmHg vs. <100 mmHg, -2.0 letters [95% CI, -4.6 to 0.5 letters]; continuous P = 0.009). Development of vision-impairing central-involved DME was more likely with higher hemoglobin A1c level (hazard ratio [HR] per 1% increase, 1.31 [95% CI, 1.13-1.52]; continuous P < 0.001), more severe diabetic retinopathy (HR for high-risk PDR or worse vs. moderate PDR or better, 1.46 [95% CI, 0.73-2.92]; continuous P = 0.03), and the presence of cystoid abnormalities within 500 μm of the macula center (HR, 2.90 [95% CI, 1.35-6.24]; P = 0.006).ConclusionsFor eyes managed with PRP, higher hemoglobin A1c level and more severe diabetic retinopathy were associated with less vision improvement and an increased risk of vision-impairing central-involved DME developing. When managing PDR with ranibizumab, eyes gained vision, on average, with no baseline characteristics identified as associated with visual acuity or central-involved DME outcomes.

Project description:PurposeTo 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.DesignRandomized clinical trial (55 United States sites).ParticipantsThree hundred ninety-four study eyes from 305 adults with PDR, visual acuity (VA) 20/320 or better, and no history of PRP.InterventionPanretinal photocoagulation or intravitreous ranibizumab injections (0.5 mg/0.05 ml).Main outcome measuresTime from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma.ResultsThrough 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).ConclusionsIn 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: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.

Dataset Information

Peripheral capillary non-perfusion in treatment-naive proliferative diabetic retinopathy associates with postoperative disease activity 6 months after panretinal photocoagulation.

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Peripheral capillary non-perfusion in treatment-naïve proliferative diabetic retinopathy associates with postoperative disease activity 6 months after panretinal photocoagulation.

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