Short-term vision gains at 12 weeks correlate with long-term vision gains at 2 years: results from the BEVORDEX randomised clinical trial of bevacizumab versus dexamethasone implants for diabetic macular oedema

2017 ◽  
Vol 102 (4) ◽  
pp. 479-482 ◽  
Author(s):  
Hemal Mehta ◽  
Samantha Fraser-Bell ◽  
Vuong Nguyen ◽  
Lyndell L Lim ◽  
Mark C Gillies
Keyword(s):  
Clinical Trial ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Randomised Clinical Trial ◽  
Macular Thickness ◽  
Central Macular Thickness ◽  
Short Term ◽  
Treatment Allocation ◽  
Visual Outcomes

AimTo determine whether early vision gains predict long-term visual outcomes in the BEVORDEX randomised clinical trial of bevacizumab or dexamethasone implants for diabetic macular oedema.MethodsPost hoc analysis of 68 study eyes (77%) that completed 2 years follow-up of the BEVORDEX multicentre randomised clinical trial set in Australia (ClinicalTrials.gov identifier: NCT01298076). Study eyes from both groups were combined and stratified by visual acuity (VA) change in the first 12 weeks in to three groups: (a) suboptimal gain: <5 letters gain (includes VA loss), (b) moderate gain: 5–9 letters gain, (c) pronounced gain: ≥10 letters gain. This was correlated with VA outcome at 104 weeks taking into account treatment allocation and baseline lens status.ResultsThe change in VA in the first 12 weeks was significantly correlated with VA change at 104 weeks (p<0.001). This was independent of treatment allocation (p=0.353) and lens status at baseline (p=0.593). The change in central macular thickness at 12 weeks did not correlate with VA gain at 104 weeks (p=0.847).ConclusionShort-term visual gain at 12 weeks was strongly correlated with long-term vision improvement independent of treatment allocation or baseline lens status. Early improvement in central macular thickness was not predictive of long-term visual outcomes.Trial registration numberNCT01298076, Post-results.

scholarly journals Effect of intravitreal Triamcinolone (2mg) on diabetic macular oedema in the pseudophakic patient as primary treatment

2020 ◽  
Vol 11 (3) ◽  
pp. 3533-3539
Author(s):  
Mohammed Qasim Al Nuwaini ◽  
Giyathaldeen T. Neameh ◽  
Mustafa A. Al Zubaidi Md ◽  
Farook M. Albusultan
Keyword(s):  
Visual Acuity ◽  
Intraocular Pressure ◽  
Intravitreal Injection ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Visual Outcome ◽  
Primary Treatment ◽  
Macular Thickness ◽  
Central Macular Thickness ◽  
Intravitreal Triamcinolone

Diabetic macular oedema is still a significant cause of vision drop in the diabetic patient with no definitive regime for treatment. This study was on the result of effects of intravitreal injection of (2mg) triamcinolone on central macular thickness measured by OCT, visual acuity and intraocular pressure in pseudophakic eyes with diabetic macular oedema as a primary treatment line followed in six months. This study is a prospective, interventional case study series. It was on patients who received intravitreal injection of Triamcinolone in a single dose of ( 2 mg/0. 05 ml). Central macular thickness by OCT, visual acuity, and intraocular pressure was measured pre-injection and 1,3,6 months after injection. This study was performed in Iraq, Baghdad, Ibn Al-Haitham Teaching Eye Hospital from October 2014 to July 2015. Results showed 25 eyes received intravitreal injection of Triamcinolone Acetoniod with pre-injection central macular thickness 597.9+98.02 µm, visual acuity 1.096+0.61 Log MAR and intraocular pressure of 16.5+ 2.53 mmHg. After six months of follow up on central macular thickness 341.6+163.1 µm, visual acuity was 0.63 + 0.40 Log MAR and IOP was 18. 04+ 5. 63mmHg. This study suggests that intravitreal injection of Triamcinolone in a dose 2mg / 0. 05ml improves both anatomical and visual outcome in 21 eyes (84%) out of 25 pseudophakic eyes with diabetic macular oedema during first six months after injection and an increase in intraocular pressure in 2 eyes (8%). The intraocular pressure was despite the use of anti-glaucoma medications during this period.

Deferiprone Versus Sequential Deferiprone-Deferoxamine Treatment in Thalassemia Major: A Five Years Multicenter Randomized Clinical Trial under the Auspices of the Society for the Study of Thalassemia and Hemoglobinopathies (SoSTE).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 575-575 ◽  
Author(s):  
Aurelio Maggio ◽  
Marcello Capra ◽  
Liana Cuccia ◽  
Francesco Gagliardotto ◽  
Carmelo Magnano ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Serum Ferritin ◽  
Statistical Significance ◽  
Thalassemia Major ◽  
Randomised Clinical Trial ◽  
Short Term ◽  
Long Term Study ◽  
One Year

Abstract Three short-term randomised clinical trials suggested not difference of Deferiprone (L1) vs Deferoxamine (DFO) in term of iron overload efficacy in thalassemia major (TM) patients. To assess whether L1 (75mg/Kg) alone was comparable to a sequential treatment using L1 (75mg/Kg) for 4 days and DFO (50mg/Kg) for 3 days, we carried ahead a large long-term randomised clinical trial. One-hundred and forty consecutive patients with TM and serum ferritin between 1,500 and 3,000 ng/ml were randomly assigned to L1 (n°69) or sequential L1-DFO (n°71) and treated for 5 years. The main measure of efficacy was the reduction of serum ferritin levels. Secondary outcomes were liver and heart iron contents assessed by T2* magnetic resonance. After one year-treatment the mean serum feritin reduction was −105 ± 90.4 in L1 and −409 ± 64.2 in sequential L1-DFO treatment (p <0.01), respectively. The greater mean serum ferritin reduction of sequential L1- DFO treatment was also confirmed all over the study (2° year L1 106 ± 713, L1-DFO -321 ± 92 (p <0.01); 3° year L1 137 ± 137, L1-DFO -292 ± 117 (p <0.05); 4° year L1 216 ± 200, L1-DFO-230 ± 170 (p <0.01); 5° year L1 336 ± 244, L1-DFO -598 ± 203 (p <0.01)). After one-year treatment this sequential group showed greater efficacy in term of serum ferritin levels reduction (−409 ± 64.2) in comparison with the DFO alone arm (−232 ± 619) of a previous randomised multicenter clinical trial in which a comparable cohort of patients were studied (p<0.05). Reversible leukocytopenia was shown in 8 (11.5%) L1 and in 7 (9.8%) sequential L1-DFO treated patients. No agranulocythosis was reported on sequential L1-DFO treated patients during the 5 years study. Hypertransaminasemia developed in 13 (18.8%) L1 and in 5 (7%) sequential L1-DFO treated patients. No other major side effects have been reported. Discontinuation of treatment was necessary in 55.6% L1 and in 57.7% sequential L1-DFO treated patients (chi2 0.03, p=0.86). The failures of treatment were less in sequential L1-DFO arm (n°2) in comparison to L1 alone arm (n°8), although this difference not so far reached the statistical significance (chi2 3.4, p=0.06). These findings suggest that sequential L1-DFO treatment in a long-term study is more effective than L1 alone with milder and reversible side effects. Moreover, its efficacy is also higher in comparison with DFO alone at short-term evaluation. Fig. 1 VARIATIONS OF THE FERRITIN LEVELS DURING FIVE YEARS TREATMENT BETWEEN THE TWO ARMS OF THE TRIAL Fig. 1. VARIATIONS OF THE FERRITIN LEVELS DURING FIVE YEARS TREATMENT BETWEEN THE TWO ARMS OF THE TRIAL

scholarly journals Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results

2020 ◽  
pp. bjophthalmol-2020-316176
Author(s):  
John F. Payne ◽  
Charles C. Wykoff ◽  
W. Lloyd Clark ◽  
Beau B. Bruce ◽  
David S. Boyer ◽  
...  
Keyword(s):  
Macular Oedema ◽  
Laser Photocoagulation ◽  
Vision Loss ◽  
Diabetic Macular Oedema ◽  
Randomised Clinical Trial ◽  
Long Term Effects ◽  
Treat And Extend ◽  
The Third ◽  
Navigated Laser

Background/aimsTo evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME).MethodsThis is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for >5 letters vision loss or if the central retinal thickness (CRT) was >325 µm, and all eyes were eligible to receive focal laser.Results109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year.ConclusionThe improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections.Trial registration numberFDA IND 119146, NCT01934556.

scholarly journals Prospective randomised clinical trial of intravitreal bevacizumab versus triamcinolone in eyes with diabetic macular oedema undergoing cataract surgery: 6-month results

2019 ◽  
pp. bjophthalmol-2018-313437 ◽  
Author(s):  
Rathika Kandasamy ◽  
Marios Constantinou ◽  
Sophie L Rogers ◽  
Sukhpal Singh Sandhu ◽  
Sanjeewa Wickremasinghe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cataract Surgery ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
Intravitreal Bevacizumab ◽  
Randomised Clinical Trial ◽  
Sustained Improvement ◽  
Significant Difference ◽  
To Receive ◽  
Significant Cataract

AimTo report the 6-month results of a clinical trial that compared intravitreous bevacizumab (BVB) 1.25 mg versus triamcinolone acetonide (TA) 4 mg when administered as an adjunct during cataract surgery to patients with diabetic macular oedema (DMO).MethodsProspective, double-masked, single-centre (Royal Victorian Eye and Ear Hospital, Melbourne) clinical trial. Patients with visually significant cataract and centre-involving DMO (either current or prior) were randomised (1: 1) to receive either intravitreous BVB 1.25 mg or TA 4 mg at the time of cataract surgery and if required at review. Main outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to the 6-month time point of this 12-month study.Results61 eyes of 58 patients were enrolled. At baseline, both groups were similar in terms of BCVA and CMT (p>0.2). At 6 months, there was no significant difference in vision between the groups, with mean letter gain of +21.4 (95% CI +14.5 to +28.4) in the TA group and +17.3 (95% CI +12.1 to +22.6) in the BVB group (p=0.35). The TA group had a significant sustained anatomical improvement at 6 months, with a reduction in CMT (−51.4 µm; 95% CI −98.2 to -4.7) compared with thickening in the BVB group (+15.6 µm; 95% CI −26.4 to +57.7, p=0.04).ConclusionsWhen given as an adjunct to cataract surgery, both TA and BVB improved visual outcomes at 6 months postoperatively. However, only TA resulted in sustained improvement in CMT, with the majority not requiring any further treatment postoperatively.

scholarly journals Intravitreal injection of a Rho-kinase inhibitor (fasudil) combined with bevacizumab versus bevacizumab monotherapy for diabetic macular oedema: a pilot randomised clinical trial

2018 ◽  
Vol 103 (7) ◽  
pp. 922-927 ◽  
Author(s):  
Hamid Ahmadieh ◽  
Ramin Nourinia ◽  
Ali Hafezi-Moghadam ◽  
Hamideh Sabbaghi ◽  
Shintaro Nakao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intravitreal Injection ◽  
Macular Oedema ◽  
Kinase Inhibitor ◽  
Rho Kinase ◽  
Diabetic Macular Oedema ◽  
Randomised Clinical Trial ◽  
Therapeutic Effects ◽  
Significant Deterioration ◽  
Rho Kinase Inhibitor

Click here to listen to the PodcastBackground/aimsTo compare the efficacy of combined intravitreal injection of bevacizumab and a Rho-kinase inhibitor, fasudil (intravitreal bevacizumab (IVB)/intravitreal fasudil (IVF)), with IVB alone for centre-involving diabetic macular oedema (DME).MethodsIn this prospective randomised clinical trial, 44 eyes with centre-involving DME were randomised into two groups. The combined group received three consecutive injections of IVB (1.25 mg) and IVF (50 µM/L) monthly, while the monotherapy group received only one IVB (1.25 mg) injection per month for 3 months. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were compared between the two groups at months 3 and 6. The primary outcome measure was the mean change in BCVA at month 6.ResultsMean BCVA was significantly improved in both groups at month 3 (P<0.001), but it persisted up to month 6 only in the IVB/IVF group. Improvement of BCVA was greater in the IVB/IVF group at both time points (P=0.008, P<0.001). In the IVB/IVF and IVB groups, 54.5% versus 10% of the eyes gained≥15 ETDRS letters at month 6 (P=0.026). Between months 3 and 6, mean BCVA significantly decreased by 5±7 ETDRS letters in the IVB group (P=0.002), while no significant deterioration was observed in the IVB/IVF group. Corresponding with the BCVA changes, CMT was significantly reduced in both groups at month 3 (p=0.006, p<0.001) but this reduction sustained only in the IVB/IVF group up to month 6 (p<0.001).ConclusionAdjunctive intravitreal injection of a Rho-kinase inhibitor may enhance and prolong the therapeutic effects of anti-vascular endothelial growth factor drugs for centre- involving DME.

scholarly journals Long-term outcomes of intravitreal therapy for symptomatic diabetic macular oedema in a real-world setting in Switzerland

2021 ◽  
Author(s):  
Johanna J. Zirpel ◽  
Isabel B. Pfister ◽  
Christin Gerhardt ◽  
Justus G. Garweg
Keyword(s):  
Real World ◽  
Macular Oedema ◽  
Diabetic Macular Oedema ◽  
First Year ◽  
Visual Outcomes ◽  
Real World Setting ◽  
Group 2 ◽  
Group 1

Abstract Objective To assess the long-term visual outcomes in eyes with symptomatic diabetic macular oedema (DME) under intravitreal treatment (IVT) in a clinical routine setting. Methods Patients with newly diagnosed DME were included in this retrospective study if they had received at least three IVTs and a follow-up period ≥ 2 years. Due to altered treatment patterns since the approval of ranibizumab for DME in 2012, patients were subdivided according to their first IVT before 2013 (group 1) or thereafter (group 2). The primary outcome measure was the evolution of best-corrected visual acuity (BCVA) over time. Results Of 217 eyes (191 patients) with DME, 151 eyes (117 patients) fulfilled the inclusion criteria (63 eyes in the first period, 88 in the second period). Mean follow-up time was 7.9 ± 3.1 (group 1) and 4.1 ± 1.4 years (group 2; p < 0.001). Visual gains were similar in the first year (group 1: + 5.3 ± 15.5, group 2: + 7.3 ± 12.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letters; p = 0.44), but not thereafter (after 2 years in group 1: + 4.4 ± 15.0, group 2: + 8.3 ± 13.0 ETDRS letters; p = 0.038). During the first year, group 1 patients received less clinical examinations (group 1: 6.6 ± 3.3, group 2: 7.5 ± 2.1; p = 0.007) and less injections (group 1: 3.6 ± 2.7, group 2: 6.1 ± 2.7; p < 0.001). Conclusion A greater visual gain, in response to more intensive treatment during the first year, was maintained for at least 5 years in group 2 subjects. Our data confirm that in a real-world setting, early intensive treatment results in satisfying long-term visual outcomes.

Clinical Outcomes, Structure, and Function Improve With Both Heavy and Moderate Loads in the Treatment of Patellar Tendinopathy: A Randomized Clinical Trial

2021 ◽  
Vol 49 (4) ◽  
pp. 982-993
Author(s):  
Anne-Sofie Agergaard ◽  
Rene B. Svensson ◽  
Nikolaj M. Malmgaard-Clausen ◽  
Christian Couppé ◽  
Mikkel H. Hjortshoej ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Randomized Clinical Trial ◽  
Clinical Outcomes ◽  
Rating Scale ◽  
Power Doppler ◽  
Patellar Tendinopathy ◽  
Short Term ◽  
Level Of Evidence

Background: Loading interventions have become a predominant treatment strategy for tendinopathy, and positive clinical outcomes and tendon tissue responses may depend on the exercise dose and load magnitude. Purpose/Hypothesis: The purpose was to investigate if the load magnitude influenced the effect of a 12-week loading intervention for patellar tendinopathy in the short term (12 weeks) and long term (52 weeks). We hypothesized that a greater load magnitude of 90% of 1 repetition maximum (RM) would yield a more positive clinical outcome, tendon structure, and tendon function compared with a lower load magnitude of 55% of 1 RM when the total exercise volume was kept equal in both groups. Study Design: Randomized clinical trial; Level of evidence, 1. Methods: A total of 44 adult participants with chronic patellar tendinopathy were included and randomized to undergo moderate slow resistance (MSR group; 55% of 1 RM) or heavy slow resistance (HSR group; 90% of 1 RM). Function and symptoms (Victorian Institute of Sport Assessment–Patella questionnaire [VISA-P]), tendon pain during activity (numeric rating scale [NRS]), and ultrasound findings (tendon vascularization and swelling) were assessed before the intervention, at 6 and 12 weeks during the intervention, and at 52 weeks from baseline. Tendon function (functional tests) and tendon structure (ultrasound and magnetic resonance imaging) were investigated before and after the intervention period. Results: The HSR and MSR interventions both yielded significant clinical improvements in the VISA-P score (mean ± SEM) (HSR: 0 weeks, 58.8 ± 4.3; 12 weeks, 70.5 ± 4.4; 52 weeks, 79.7 ± 4.6) (MSR: 0 weeks, 59.9 ± 2.5; 12 weeks, 72.5 ± 2.9; 52 weeks, 82.6 ± 2.5), NRS score for running, NRS score for squats, NRS score for preferred sport, single-leg decline squat, and patient satisfaction after 12 weeks, and these were maintained after 52 weeks. HSR loading was not superior to MSR loading for any of the measured clinical outcomes. Similarly, there were no differences in functional (strength and jumping ability) or structural (tendon thickness, power Doppler area, and cross-sectional area) improvements between the groups undergoing HSR and MSR loading. Conclusion: There was no superior effect of exercising with a high load magnitude (HSR) compared with a moderate load magnitude (MSR) for the clinical outcome, tendon structure, or tendon function in the treatment of patellar tendinopathy in the short term. Both HSR and MSR showed equally good, continued improvements in outcomes in the long term but did not reach normal values for healthy tendons. Registration: NCT03096067 (ClinicalTrials.gov identifier)

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