Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery – preliminary 6 month results

Abstract

Background: To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME).Design: Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne.Participants: Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months.Methods: Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months.Main Outcome Measures: Change in central macular thickness (CMT) and best corrected visual acuity at 6 months.Results: Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (À43.8-μm reduction TA vs. +37.3-μm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group.Conclusions: When administered at the time of cataract surgery in patients with DME, at 6 months both

Comparison of the Efficacy of Sub-Tenon versus Intravitreal Triamcinolone Acetonide Injection during Cataract Surgery for Diabetic Macular Edema

“…Recently, intravitreal injections of VEGF agents such as bevacizumab, ranibizumab, and aflibercept have become the standard therapy for DME worldwide [6,7]. However, these agents do not significantly reduce the macular thickness in eyes with DME after CS [8,9]. This is probably because cytokines other than VEGF are involved in the onset and the progression of DME after CS [5], and anti-VEGF agents cannot reduce the levels of these other cytokines in eyes with DME [10].…”

“…A recent randomized prospective clinical trial demonstrated that IVTA can reduce central macular thickness (CMT) for 6 months after CS in eyes with DME, but that intravitreal bevacizumab injection did not reduce CMT even after multiple injections [9]. Thus, IVTA may be better than anti-VEGF injections after CS for the treatment of DME.…”

Prevention and treatment of cystoid macular edema after cataract surgery

“…Although visual acuity may decrease after cessation of treatment, visual acuity recovered in most patients after retreatment with NSAID eye drops. 49,50 Moreover, small studies suggest that a combination treatment with a topical corticosteroid and NSAID is more effective than a topical corticosteroid alone. The time to resolution of PCME was significantly shorter in patients treated with a combination of topical corticosteroids and NSAIDs.…”

“…Increased IOP is a common complication of local corticosteroid administration, but prevalence may vary between various routes of administration. [48][49][50][51] Other routes of corticosteroid administration may also prevent the occurrence of CME, involving a lower incidence of IOP increase. Previous studies have investigated the use of high frequency prednisolone eye drops, oral prednisolone, intravitreal TA, and subtenon TA.…”

“…50 The review compares the efficacy of various pharmacological strategies to prevent CME within three months after cataract surgery, in diabetic and non-diabetic patients without CME preoperatively.…”