1.
Anti-Vascular Endothelial Growth Factor Injections: The New Standard of Care in Proliferative Diabetic Retinopathy?
Li, X, Zarbin, MA, Bhagat, N
Developments in ophthalmology. 2017;:131-142
Abstract
For decades, panretinal photocoagulation (PRP) has been the standard of care for the treatment of proliferative diabetic retinopathy (PDR). The relatively recent advent of anti-vascular endothelial growth factor (VEGF) formulations for intravitreal injection has provided a fresh perspective on PDR treatment, especially in eyes with concurrent diabetic macular edema (DME). The anti-VEGF agent ranibizumab has demonstrated a potentially protective effect on eyes with DME in terms of progression to PDR in the RIDE/RISE trials, as has aflibercept in the VIVID/VISTA trials. In 2015, these 2 agents were approved by the Food and Drug Administration for the treatment of PDR with DME, though PRP still remains the standard of care for eyes without baseline DME. Published results from Protocol S illustrate the non-inferiority of ranibizumab versus PRP in the treatment of PDR, the first prospective study to do so in eyes with and without baseline DME. These results also reveal that treatment with ranibizumab, when compared to standard treatment with PRP, may also lead to less peripheral visual field loss, reduced need for vitrectomy, and reduced chance for developing DME. Both PRP and intravitreal ranibizumab have very low rates of adverse events. However, treatment with anti-VEGF agents generally is associated with higher costs, increased need for follow-up, and the risk of potentially catastrophic ocular complications (e.g., endophthalmitis) and systemic side effects. Anti-VEGF agents should be considered in cases of media opacity preventing completion of PRP in compliant patients without recent cerebrovascular accident or myocardial infarction, though the long-term efficacy of these agents remains to be studied, especially after the discontinuation of injections.
2.
INTRAVITREAL CONBERCEPT (KH902) FOR SURGICAL TREATMENT OF SEVERE PROLIFERATIVE DIABETIC RETINOPATHY.
Su, L, Ren, X, Wei, H, Zhao, L, Zhang, X, Liu, J, Su, C, Tan, L, Li, X
Retina (Philadelphia, Pa.). 2016;(5):938-43
Abstract
PURPOSE To evaluate the role, safety, and effectiveness of intravitreal conbercept (KH902) injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy. METHODS A randomized controlled trial was performed on 36 eyes of 36 patients affected by vitreous hemorrhage and tractional retinal detachment, which occurred as a consequence of active proliferative diabetic retinopathy. The patients were randomly assigned to two groups. The patients in one of the groups received an intravitreal injection of conbercept in the inferior temporal sector 4 mm from the sclerocorneal limbus with a sterile technique 1 week before vitrectomy. RESULTS In the group without conbercept, intraoperative bleeding occurred in 14 patients (77.8%), and in five of these cases, bleeding was significant. The use of endodiathermy was necessary in 8 patients (44.4%). In 3 patients (16.6%), iatrogenic retinal breaks occurred, and in 1 patient (5.5%), a relaxing retinotomy was performed. Endotamponade with silicone oil was performed in 12 patients (66.6%). In the group treated with conbercept, intraoperative bleeding occurred in 2 cases (11.1%). The use of endodiathermy was necessary in 1 patient (5.5%). No patients experienced iatrogenic breaks or relaxing retinotomy during the surgery. Endotamponade with silicone oil was performed in 2 patients (11.1%). CONCLUSION Preoperative intravitreal injection of conbercept could reduce the chances of intraoperative bleeding, which are beneficial in the management of proliferative diabetic retinopathy.
3.
The REVEAL Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy in Asian Patients with Diabetic Macular Edema.
Ishibashi, T, Li, X, Koh, A, Lai, TY, Lee, FL, Lee, WK, Ma, Z, Ohji, M, Tan, N, Cha, SB, et al
Ophthalmology. 2015;(7):1402-15
Abstract
OBJECTIVE The primary study hypothesis was that ranibizumab 0.5 mg monotherapy or combined with laser is superior to laser monotherapy based on mean average change in best-corrected visual acuity (BCVA) over 12 months in Asian patients with visual impairment resulting from diabetic macular edema (DME). DESIGN A 12-month, randomized, double-masked, multicenter, laser-controlled, phase III study. PARTICIPANTS Three hundred ninety-six patients aged ≥18 years, with type 1 or 2 diabetes mellitus, BCVA of 78-39 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and visual impairment resulting from DME. METHODS Patients were randomized to ranibizumab + sham laser (n = 133), ranibizumab + active laser (n = 132), or sham injection + active laser (n = 131). Ranibizumab/sham injections were administered on day 1 and continued monthly. As of month 3, monthly injections were continued if stable vision was not reached. Treatment was reinitiated if BCVA decreased because of DME progression. Active/sham laser was administered on day 1 and thereafter according to ETDRS guidelines. MAIN OUTCOME MEASURES Average change in BCVA from baseline to months 1 through 12, central retinal subfield thickness (CRST), and safety over 12 months. RESULTS Ranibizumab monotherapy or combined with laser was superior to laser in improving mean average change in BCVA from baseline to months 1 through 12 (+5.9 and +5.7 vs +1.4 letters). At month 12, greater proportion of patients gained ≥15 letters with ranibizumab and ranibizumab + laser compared with laser (18.8% and 17.8% vs 7.8%). Mean CRST reduced significantly from baseline to month 12 with ranibizumab (-134.6 μm) and ranibizumab + laser (-171.8 μm) versus laser (-57.2 μm). Patients received a mean of 7.8 and 7.0 ranibizumab injections in the ranibizumab and ranibizumab + laser arms, respectively, and 1.5-1.9 active laser across treatment arms over 12 months. Conjunctival hemorrhage was the most common ocular, whereas nasopharyngitis and hypertension were the most common nonocular adverse events. Ranibizumab was not associated with any cases of cerebrovascular hemorrhage and cerebrovascular ischemia. No death related to study treatment was reported. CONCLUSIONS Ranibizumab monotherapy or combined with laser showed superior BCVA improvements over laser treatment alone in Asian patients with visual impairment resulting from DME. No new ocular or nonocular safety findings were observed and treatment was well tolerated over 12 months.