scholarly journals Postmarketing safety surveillance of dexamethasone intravitreal implant in the treatment of visual impairment due to diabetic macular edema in India

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Unnikrishnan Nair ◽  
◽  
Vishali Gupta ◽  
Mohita Sharma ◽  
Shrinivas Joshi ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Visual Impairment ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Surveillance Study ◽  
World Health ◽  
Diabetic Patients

Abstract Background Diabetic macular edema (DME) is the most common cause of vision loss in diabetic patients. As India has the second largest population of diabetic patients worldwide, availability of various treatment options for DME is essential. This postmarketing surveillance study was conducted to fulfill a commitment to the Regulatory Authority of India to examine the safety of dexamethasone intravitreal (DEX) implant over 1 year in Indian patients with DME receiving ≥1 DEX implant for DME-related visual impairment in clinical practice. Methods This observational, prospective, non-interventional study enrolled patients aged ≥18 years scheduled to receive DEX implant for DME-related visual impairment. Baseline demographics, medical history, date of last DEX implant injection, detailed information about adverse events (AEs), AEs of special interest (AESIs), serious AEs (SAEs), and adverse drug reactions (ADRs) reported during postinjection visits and investigator telephone calls were collected. Primary outcome measures were treatment-emergent AE (TEAE), AESI, SAE, and ADR occurrences. Results Of the enrolled patients (19 sites throughout India; n = 250), 84 had received DEX implant previously; mean (standard deviation; SD) duration between prior and study entry dose was 199.4 (156.0) days, and 91 (36.4%) had ≥1 prior ophthalmic condition. Over a mean of 182.6 (88.6) follow-up days (min–max: 0–364 days), 22 TEAEs were reported by 7 (2.8%) patients, 6 of whom had previously received DEX. AESIs of increased IOP (n = 3, 6 events) and glaucoma (n = 1, 1 event) were considered non-serious, of mild/moderate severity, and related to DEX treatment. Eyelid ptosis was reported in 1 patient (1 event). Nonocular AEs included cardiac AEs (n = 3, 4 events), pyrexia (n = 1, 2 events), and dyspnea (n = 1, 2 events). Three (1.2%) patients had 12 serious AEs; most were cardiac disorders; all were unrelated to DEX treatment. Two (0.8%) deaths were considered unrelated to treatment. Conclusions Based on voluntary reporting of adverse events in this surveillance study, DEX implant for treatment of DME-related visual impairment in the Indian population demonstrated a favorable safety profile with few treatment-related TEAEs (none were considered serious) during the 1-year follow-up. These data supplement previous findings and confirm the safety of DEX implant in this population during usual clinical practice. Trial registration World Health Organization Clinical Trials Registry: CTRI/2017/04/008396. Registered 24 April 2017.

Clinical Diagnosis and New Classification of Diabetic Retinopathy and Diabetic Macular Edema

2018 ◽  
pp. 119-123
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Diabetic Patients ◽  
Common Causes ◽  
Diagnosis Classification

Diabetic retinopathy and diabetic macular edema are the most common causes of preventable blindness among the working class in many countries. The prevalence of diabetic macular edema, which is frequently associated with vision loss, is increasing. Classification of diabetic retinopathy is essential for precise and punctual treatment and follow-up, and ultimately for enhancing the quality of life of diabetic patients. Studies in recent years have shared protocols for diagnosis, classification, and follow-up.

scholarly journals Real-world outcomes of two-year Conbercept therapy for diabetic macular edema

2021 ◽  
Vol 14 (3) ◽  
pp. 416-422
Author(s):  
Yong Cheng ◽  
◽  
Ming-Wei Zhao ◽  
Tong Qian ◽  
◽  
...  
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Retinal Thickness ◽  
Corrected Visual Acuity ◽  
The Mean ◽  
Number Of Injections ◽  
Best Corrected Visual Acuity

AIM: To evaluate the two-year outcomes of patients treated for diabetic macular edema (DME) with intravitreal Conbercept (IVC). METHODS: The clinical data of 30 DME patients (36 eyes) were retrospectively reviewed. The patients were treated with IVC for 3mo. Additional IVC was given at subsequent monthly visits, if needed (3+PRN). The patients were followed up for 24mo. RESULTS: The best-corrected visual acuity (BCVA) at 24mo significantly increased (66.7±15.3 letters) in comparison with the baseline (54.4±15.4 letters, P<0.0001). The mean improvement in BCVA was 11.0±2.9 letters. At 24mo, 44.1% of the eyes surveyed gained ≥15 letters, 52.9% of the eyes gained ≥10 letters, and 70.6% of the eyes gained ≥5 letters. No vision loss was noted in 96.8% of the eyes, and 5.9% of the eyes lost ≥5 letters, but ≤10 letters. The central retinal thickness (CRT) at 24mo was significantly reduced (277.1±122.9 μm) in comparison with the baseline (510.9±186.1 μm, P<0.0001). At 24mo, 43.3% of the patients had a CRT ≤250 μm. The mean number of injections over 24mo was 10.6±2.0. No severe eye or systemic adverse events related to either the drug or injection were noted. CONCLUSION: IVC is safe and effective for the treatment of DME.

scholarly journals The Evolving Treatment Options for Diabetic Macular Edema

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Atul Jain ◽  
Neeta Varshney ◽  
Colin Smith
Keyword(s):  
Diabetic Retinopathy ◽  
Visual Impairment ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Treatment Options ◽  
Previous Treatment ◽  
Common Cause ◽  
Working Age

Diabetic retinopathy (DR) is the leading cause of vision loss in working-age adults, and diabetic macular edema (DME) is the most common cause of visual impairment in individuals with DR. This review focuses on the pathophysiology, previous treatment paradigms, and emerging treatment options in the management of DME.

scholarly journals Review on Recent Trials Evaluating the Effect of Intravitreal Injections of Anti-VEGF Agents on the Macular Perfusion of Diabetic Patients with Diabetic Macular Edema

2020 ◽  
Vol 15 (3) ◽  
pp. 188-198
Author(s):  
Ayman G. Elnahry ◽  
Ahmed A. Abdel-Kader ◽  
Ahmed E. Habib ◽  
Gehad A. Elnahry ◽  
Karim A. Raafat ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Case Series ◽  
Diabetic Patients ◽  
Long Term Effects ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Anti Vegf

Background: Diabetic macular edema (DME) is a major cause of vision loss in diabetics worldwide. Anti-vascular endothelial growth factor (anti-VEGF) agents have become the mainstay of treatment of vision loss due to DME. Long-term effects of these agents on the macular perfusion (MP) are a current concern. Objective: To review recently published studies that evaluated the effect of intravitreal injection of anti-VEGF agents on the MP of diabetics with DME. Methods: Different databases were searched including PubMed, Medline, Ovid, Science Direct, and Google Scholar for relevant studies published between 2010 and 2019. All studies found were compared regarding methodology and results and included in this review. Some studies relating to retinal perfusion in general and not strictly MP were also included for comprehensiveness. Results: Several studies utilizing different anti-VEGF agents were identified. All the large randomized controlled clinical trials identified utilized primarily fluorescein angiography (FA) and human graders and found generally no worsening of MP associated with anti-VEGF agents use in diabetic patients with DME. Some of these studies, however, depended on post-hoc analysis. Several more recent, but smaller case series, have utilized the relatively new and non-invasive optical coherence tomography angiography (OCTA) in this evaluation and found more conflicting results. Conclusion: The large clinical trials recently performed depended mainly on FA in the analysis of MP changes following injections and generally found no worsening of MP. More recently, smaller case series have utilized OCTA in this analysis, yielding more conflicting results. Large randomized controlled trials using OCTA are thus needed.

scholarly journals Treatment Efficacy and Compliance in Patients with Diabetic Macular Edema Treated with Ranibizumab in a Real-Life Setting

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Anne-Laurence Best ◽  
Franck Fajnkuchen ◽  
Sylvia Nghiem-Buffet ◽  
Typhaine Grenet ◽  
Gabriel Quentel ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Real Life ◽  
Treatment Compliance ◽  
Age Related Macular Degeneration ◽  
Age Related ◽  
Real Life Setting ◽  
The Mean

Purpose. To assess real-life efficacy of ranibizumab and treatment compliance of patients with vision loss secondary to diabetic macular edema (DME). Methods. A retrospective study was conducted in DME patients treated with ranibizumab. Patients were monitored every 4 weeks for visual acuity (VA) and central retinal thickness (CRT) by SD-OCT. All patients received a loading dose of 3 monthly injections followed by retreatments on an as-needed basis. The primary endpoint was the change in VA at M12. Patient compliance to the follow-up and the correlation between the injection number and VA were also investigated. Compliance was compared to that of neovascular age-related macular degeneration (nAMD) patients. Results. Seventy-two eyes of 55 consecutive DME patients were included. At baseline, the mean VA was 56.5 letters and CRT was 470 μm. At M12, the mean VA was 63.4 letters (p<0.0001), 31.1% of patients had a VA > 70 letters, the mean VA change was +6.9 letters, and the mean CRT was 361.9 μm (p=0.0001) after a mean number of 5.33 intravitreal injections. In patients who received ≥7 injections, the VA gain and final VA were significantly higher than in patients who received <7 injections. At M12, 25.45% of DME patients were lost to follow-up versus 16.8% of nAMD patients (n=55). Discussion/Conclusion. Our study confirms the real-life efficacy of ranibizumab in DME at M12 and the need for a large number of injections to achieve better visual outcomes. We also showed a trend to a lower compliance in diabetic versus nAMD patients.

scholarly journals DIABETIC MACULAR EDEMA;

2018 ◽  
Vol 21 (04) ◽  
pp. 810-815
Author(s):  
Fuad Ahmad Khan Niaz ◽  
Bilal Humayun Mirza ◽  
Manal Niazi ◽  
Muhammad Afzal Khan Niaz
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Outcome Measure ◽  
Case Series ◽  
Intravitreal Bevacizumab ◽  
Diabetic Patients ◽  
Main Outcome Measure ◽  
Clinically Significant Macular Edema ◽  
Clinically Significant

. OBJECTIVE: To evaluate the effect of Intravitreal Bevacuzimab on Best CorrectedVisual Acuity in patients with clinically significant diabetic macular edema. MATERIAL ANDMETHODS: A prospective uncontrolled interventional case series in which 42 eyes of 31consecutive diabetic patients with clinically significant macular edema and no significantcomorbid ocular association presenting in the outpatients department of Holy Family Hospitaland EYE SURGERY clinic, Rawalpindi Pakistan and opting for the treatment from 1st September2013 to 31st January 2014 were given an intravitreal injection of Bevacizumab. BCVA wasdocumented prior to and four weeks after the injection. Main outcome measure was changes inBCVA. RESULTS: Out of the 31 patients included in the study 14(45.16%) were male and 17(54.83%) female. Average age was 56.1 ± 7.6. All 31 patients (42 eyes) came for follow up andtheir BCVA recorded. 41 (97.61%) eyes showed an improvement of one or more line on Snellen'schart at 4 weeks. 14 (33.33%) eyes showed an improvement of one line, 19 (45.23%) eyes animprovement of two lines, 6 (14.28%) eyes three lines and just 2 (4.76%) eyes had animprovement of four lines on Snellen's chart at 4 weeks. Only 1(2.38%) eye remained same withno worsening. On logMAR conversion scale for Snellen's letters the BCVA improved from 0.76 ±0.27 to 0.47 ± 0.27 (p< 0.001). No significant complications were observed in any of the eyes.CONCLUSION: The use of intravitreal Bevacizumab (1.25mg/0.05ml) is a safe and effective moeof treatment for clinically significant diabetic macular edema.

scholarly journals Diabetic Macular Edema Patients with Poor Baseline Visual Acuity Treated with Ranibizumab in Real Life and Optical Coherence Tomography Based Predictor Factors for Visual Outcomes

2018 ◽  
Vol 08 (02) ◽  
pp. 008-014
Author(s):  
Abdullah Ozkaya ◽  
Mehmet Ozveren ◽  
Okkes Baz ◽  
Hatice Nur Tarakcioglu ◽  
Korhan Fazil ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Real Life ◽  
Life Outcomes ◽  
Stable Vision ◽  
The Mean ◽  
Baseline Visual Acuity

Abstract Purpose: We aimed to evaluate the real life outcomes of ranibizumab in the treatment of diabetic macular edema (DME) patients with a baseline visual acuity<0.05 in decimals. Methods: Newly diagnosed DME patients with a visual acuity ≤0.05, treated with ranibizumab monotherapy, and completed a follow-up time of 12 months were included retrospectively. Patients were evaluated in regards to change in best corrected visual acuity (BCVA) and central retinal thickness, and the total visit and injection numbers. Results: A total of 24 eyes of 24 patients were included. Mean BCVA at baseline, month 3, 6, 9, and 12 was, 0.04±0.01, 0.12±0.12, 0.12±0.11, 0.17±0.19, and 0.21±0.21 (p<0.05 for all), respectively. One eye (4.2%) had VA loss of ≥3 lines, and six eyes (25.0%) had stable vision (loss of <3 line, or remained stable, or gained <1 lines), and 17 eyes (70.8%) had VA gain of ≥3 lines at month 12.The mean visit number at month 12 was 4.8±1 and the mean injection number was 4.0 ±1.4. Conclusion: Ranibizumab seemed to be effective in the treatment of DME patients with a low visual acuity in real life.

scholarly journals Subthreshold micropulse laser adjuvant to bevacizumab versus bevacizumab monotherapy in treating diabetic macular edema: one- year- follow-up

2021 ◽  
Vol 13 ◽  
pp. 251584142110408
Author(s):  
Leila El Matri ◽  
Ahmed Chebil ◽  
Khaled El Matri ◽  
Yousra Falfoul ◽  
Zouheir Chebbi
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Intravitreal Injections ◽  
Control Group ◽  
Diabetic Patients ◽  
Micropulse Laser ◽  
Treatment Naïve ◽  
The Difference ◽  
Retrospective Comparative Study

Purpose: To compare the therapeutic impact of combining intravitreal injections of bevacizumab (IVB) with micropulse laser (MPL) in central diffuse diabetic macular edema (DME) versus IVB monotherapy during 12 months follow-up. Methods: We conducted a retrospective comparative study of 98 treatment-naive eyes (63 patients) with central diffuse DME. The first group of patients (IVB + MPL group, n = 49) was treated with 3 monthly IVB followed by MPL within 1 week after the third injection. Patients were then followed and treated on a pro re nata (PRN) basis, with MPL retreatment if necessary. The changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), number of IVB injections and MPL sessions were evaluated at 4, 8, and 12 months. A control group of diabetic patients with treatment-naive DME was treated with standard protocol of 3 monthly IVB as monotherapy then followed on a PRN basis (IVB group, n = 49). Statistic comparaison of BCVA, CMT, and IVB number variation was interpreted at 12 months between both groups. Results: In IVB + MPL group, baseline BCVA improvement was not significant at 4 and 8 months ( p = 0.90, p = 0.08), and was statistically significant ( p = 0.01) at 12 months. Mean CMT significantly decreased at 4, 8, and 12 months ( p < 0.01) in IVB + MPL group. The difference in BCVA (p = 0.091) and CMT (p = 0.082) variation at 12 months between both groups was not significant but the number of injections was significantly lower in IVB + MPL group (4.1 ± 1.5 injections) compared to IVB group (7.2 ± 1.3 injections) ( p < 0.005). Conclusion: Combining intravitreal injections of bevacizumab and MPL in the treatment of DME is effective and safe. This protocol may decrease the number of IVB and its frequency. It offers the advantage of lasting therapeutic response with fewer recurrences.

Risk of Systemic Adverse Events Associated with Intravitreal Anti–VEGF Therapy for Diabetic Macular Edema in Routine Clinical Practice

Ophthalmology ◽  
2019 ◽  
Vol 126 (7) ◽  
pp. 1007-1015 ◽  
Author(s):  
Maya H. Maloney ◽  
Stephanie R. Schilz ◽  
Jeph Herrin ◽  
Lindsey R. Sangaralingham ◽  
Nilay D. Shah ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Routine Clinical Practice ◽  
Anti Vegf

scholarly journals Management of diabetic macular edema patients in clinical practice in Spain

2018 ◽  
Vol 29 (6) ◽  
pp. 664-672 ◽  
Author(s):  
Rodrigo Abreu-Gonzalez ◽  
Roberto Gallego-Pinazo ◽  
Maximino Abraldes ◽  
Isabel Pinilla ◽  
María I Lopez-Galvez
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Clinical Practice ◽  
Growth Factor ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vascular Endothelial ◽  
Actual Clinical Practice ◽  
Almost All ◽  
Endothelial Growth Factor

Purpose: Diabetic macular edema is the main cause of blindness in diabetic patients. Vascular endothelial growth factor is involved in diabetic macular edema pathogenesis. Vascular endothelial growth factor inhibitors are an important option in diabetic macular edema therapy. This survey investigates actual clinical practice in diabetic macular edema in Spain. Methods: An expert advisory panel of 17 Spanish ophthalmologists developed a 30-item anonymous questionnaire about diagnosis, treatment, and follow-up in diabetic macular edema. A total of 137 ophthalmologists from 10 Spanish regions completed the questionnaire online. Results: Almost all of the respondents (99.3%) record the measured visual acuity and perform biomicroscopic anterior (94.9%) and posterior (91.2%) segment examinations. Similarly, 100% of responding ophthalmologists always/almost always or frequently perform optical coherence tomography. Most respondents (65%) always/almost always or frequently perform a retinography. More than 50% rarely perform fluorescein angiography. Nearly, all (96.4%) of the specialists responded that, in center-involved diabetic macular edema, the first treatment is an anti–vascular endothelial growth factor drug. For corticosteroids, the first choice of most respondents (91.2%) was the dexamethasone implant. In the follow-up, almost all (96.4%) specialists record the measured visual acuity and most also perform biomicroscopic anterior (82.5%) and posterior (83.2%) segment examination. Conclusion: This survey shows the actual clinical practice in diabetic macular edema in Spain, finding that anti–vascular endothelial growth factor therapy is frequently used, and that diagnosis, treatments, and follow-up examinations used by specialists are homogeneous and according to diabetic macular edema guidelines.

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