Clinical observation of Dan-Hong Hua-Yu oral solution in treating retinal vein occlusion.

INTRODUCTION: Retinal vein occlusion refers to diseases with decreased vision, dilated tortuous retinal veins visible on the fundus, and retinal hemorrhage, edema, and osmosis distributed along the vein. There is still no ideal intervention to treat central retinal vein occlusion. This study plan to observe the efficacy of Dan-Hong Hua-Yu oral solution in treating non-ischemic retinal vein occlusion, in order to provide new treatment ideas. METHODS/DESIGN: We plan to use random number table method, 64 cases of non-ischemic central retinal vein occlusion that meet the inclusion criteria will be randomly divided into a treatment group and a control group. The intervention group will be treated with Dan-Hong Hua-Yu oral solution according to the syndrome differentiation of Traditional Chinese medicine and the patient's fundus condition. Each group will take 4 weeks as a course of treatment and three consecutive courses of treatment without any interval during the course of treatment. Changes of visual acuity, fundus performance, and total clinical symptoms of patients before and after treatment will be observed. DISCUSSION: This study will observe the efficacy of Dan-Hong Hua-Yu oral solution in the treatment of non-ischemic central retinal vein occlusion, with a view to providing new treatment ideas. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000030625, Registered on March 08, 2020.

Risuteganib-a novel integrin inhibitor for the treatment of non-exudative (dry) age-related macular degeneration and diabetic macular edema.

INTRODUCTION: Non-exudative (dry) age-related macular degeneration (AMD) and diabetic macular edema (DME) are leading causes of vision loss worldwide. Besides age-related eye disease study (AREDS) vitamin supplements, there are no efficacious pharmaceutical interventions for dry AMD available. While numerous pharmacologics are available to treat diabetic macular edema (DME), many patients respond suboptimally to existing therapies. Risuteganib is a novel anti-integrin peptide that targets the multiple integrin heterodimers involved in the pathophysiology of dry AMD and DME. Inhibiting these selected integrin heterodimers may benefit patients with these conditions. AREAS COVERED: This article offers a brief overview of current pharmaceuticals available for dry AMD and DME. The proposed role of integrins in AMD and DME is reviewed and later, risuteganib, a novel anti-integrin peptide is introduced. The data from initial Phase 1 and Phase 2 risuteganib clinical trials are discussed in the latter part of the paper. EXPERT OPINION: While there are currently limited treatment options for dry AMD, more data are needed before we can truly evaluate the benefits of adopting risuteganib into the clinic. Conversely, several effective treatment options exist for DME; hence, risuteganib must show that it can add to these results, especially in those with refractory disease, before retina specialists adopt risuteganib into their treatment regimens.

The effects of hyperbaric oxygen therapy on diabetic retinopathy: A preliminary study.

PURPOSE: The objective of this study was to prospectively assess the effect of hyperbaric oxygen therapy (HBOT) on diabetic retinopathy lesions and macular edema in patients undergoing the treatment for diabetic foot ulcers. METHODS: We compared two groups: a first group including 25 patients with non-proliferative diabetic retinopathy treated by HBOT for foot ulcers, and a second group (control group) composed of 25 patients with diabetic retinopathy who did not receive HBOT. The HBOT protocol performed for the patients in the first group was: 30 sessions of 90 minutes each at 2.5 ATA with a mean frequency of five sessions per week. All patients had an ophthalmological exam at baseline (visual acuity, intraocular pressure, fundus exam), fundus photography and an OCT exam. A follow-up exam was performed at the conclusion of the HBOT. RESULTS: Compared to the control group, patients treated with HBOT showed a regression or stabilization of diabetic retinopathy lesions and a decrease in central macular thickness (CMT). CONCLUSION: Hyperbaric oxygen therapy may improve diabetic retinopathy and diabetic macular edema. This therapy may serve as an adjunctive treatment in the management of retinal ischemia and capillary hyperpermeability in diabetic retinopathy.

Oral administration of a curcumin-phospholipid formulation (Meriva®) for treatment of chronic diabetic macular edema: a pilot study.

OBJECTIVE: The purpose of this open-label study was to investigate the effect of a curcumin-phospholipid lecithin formulation (Meriva®) on visual acuity and optical coherence tomography (OCT) retinal thickness in patients with chronic diabetic macular edema. PATIENTS AND METHODS: Curcumin-phospholipid lecithin formulation (Meriva®, Indena S.p.A, Milan, Italy) was administered as tablets (Norflo®, Eye Pharma, Genoa, Italy) twice a day. Visual acuity and macular edema as measured by OCT before and after curcumin-phospholipid formulation treatment were assessed. RESULTS: The study included 12 eyes from 11 patients who completed at least a 3-month follow-up period. After 3 months of therapy, no eyes showed reduction in visual acuity, 16% showed stabilization, and 84% showed improvement. The improvement was statistically significant (p = 0.0072). After 3 months of therapy, 92% of eyes showed reduction of macula edema, 8% showed stabilization, and 0% showed an increase (p = 0.009). CONCLUSIONS: Our results, albeit preliminary, suggest that a curcumin-phospholipid formulation (Meriva®), administered as Norflo® tablets, may be feasible in the improvement of visual acuity and reduction of macular edema in patients with diabetic retinopathy.

Photobiomodulation in the treatment of patients with non-center-involving diabetic macular oedema.

PURPOSE: Far-red/near-infrared phototherapy or photobiomodulation (PBM) has recently been reported to be an effective and non-invasive treatment method to inhibit lesions of diabetic retinopathy (DR) in animals. This study investigated the safety and efficacy of PBM in diabetic patients to treat non-center-involving diabetic macular oedema (NCDME). METHODS: This was a non-randomised, consecutive, case series, where 4 patients with type 2 diabetes with NCDME were treated for 160 s per day with PBM for 2-9 months. Demographic data including age, sex, HbA1c%, electronic ETDRS visual acuity, and retinal and macular thickness were measured using spectral domain ocular coherence tomography (SD-OCT) before and after treatment. RESULTS: Four eyes of 4 patients were treated, with fellow eyes serving as untreated controls. Daily PBM treatment for only 80 s per treatment twice daily caused a significant reduction in focal retinal thickening in all 4 treated eyes. No adverse effects attributable to therapy were noted by the patients or study investigators during the study period. CONCLUSIONS: PBM potentially offers a non-invasive and cost-effective therapeutic option for patients with NCDME. Further studies of this therapeutic option in DR are warranted.

Regression of early diabetic macular oedema is associated with prevention of dark adaptation.

HYPOTHESIS: Dark-adapted rods consume oxygen at high rates and light adaptation decreases this oxygen burden and can have therapeutic effects on diabetic macular oedema (DMO). METHODS: Patients with mild non-proliferative diabetic retinopathy (DR) and early, untreated non-sight-threatening DMO slept for 6 months wearing masks that illuminated the eyelid of one closed eye by 505 nm light. Exclusion criteria were any concomitant eye disease, DR >ETDRS grade 35, and other systemic diseases. PRIMARY OUTCOME: change of OCT retinal thickness in the local region where oedema was present. RESULTS: A total of 34 out of 40 patients completed the study. Mean baseline OCT macular cube thickness was equivalent for study and fellow eyes. But study eyes had a greater mean thickness in the central subfield zone 1 (282±53 µm) vs (256±19 µm) the fellow eyes. Twenty-eight study eyes showed intraretinal cysts compared with nine in the fellow eyes. At 6 months, only 19 study eyes had cysts while cysts were seen in 20 fellow eyes. After 6 months, the worst affected ETDRS zone and the central subfield zone 1 reduced in thickness in study eyes only by 12 µm (95% CI 20 to -7, P=0.01). The secondary outcomes of change in visual acuity, achromatic contrast sensitivity, and microperimetric thresholds improved significantly in study eyes and deteriorated in fellow eyes. CONCLUSIONS: Sleeping in dim light that can keep rods light adapted may reverse the changes of DMO.

Combination of flavonoids with Centella asiatica and Melilotus for diabetic cystoid macular edema without macular thickening.

PURPOSE: The purpose of this study was to evaluate the orally administered combination of flavonoids desmin and troxerutin with Centella asiatica and Melilotus for the treatment of diabetic cystoid macular edema (CME) without macular thickening. METHODS: In this prospective, interventional, controlled study, 40 consecutive patients with type 2 diabetes and CME without macular thickening at optical coherence tomography were randomized into 2 groups of 20 subjects each (treatment and control groups). The treatment group received an oral combination of desmin (300 mg/day) and troxerutin (300 mg/day) with C. asiatica (30 mg/die) and Melilotus (160 mg/die) for 14 months. Best collected visual acuity, central retinal thickness at optical coherence tomography, retinal sensitivity (RS), and stability of fixation at microperimetry were measured at baseline and monthly for 14 months. RESULTS: In both groups, mean best collected visual acuity, central retinal thickness, and stability of fixation did not show differences during follow-up (P > 0.05). At month 14, the RS was greater in the treated group (P = 0.01) and was significantly reduced in the control group only (P < 0.001). Five eyes in the study group showed disappearance of the intraretinal cysts after a mean time of 3.5 ± 0.3 months, which persisted in the following months. These 5 eyes presented a greater RS at each follow-up visit when compared with the control group (P < 0.05). Anatomic improvement was never reported in the control group. CONCLUSIONS: The orally administered combination of flavonoids, C. asiatica, and Melilotus could be beneficial in preserving RS in diabetic CME without macular thickening.

Resolution of macular oedema in occult choroidal neovascularization under oral Sorafenib treatment.

PURPOSE: To report on the effect of oral nexavar (Sorafenib) treatment in one patient with neovascular age-related macular degeneration (AMD) and advanced renal cell cancer (RCC). METHODS: After two intravitreal injections of bevacizumab (1.25 mg) for occult choroidal neovascularization (CNV) in AMD, the patient was started on oral Sorafenib (400 mg twice daily) treatment for RCC. RESULTS: Visual acuity (VA) was 20/80 in the left eye and optical coherence tomography (OCT) demonstrated persistent central thickening to 251 microm after bevacizumab. After 6 weeks of oral Sorafenib treatment, VA had increased to 20/70 and a significant decrease in retinal thickness to 208 microm was observed on OCT. The patient remained stable during a further 3 months of follow-up. CONCLUSIONS: Resolution of macular oedema and stabilization of VA under oral treatment with the multikinase inhibitor Sorafenib was observed. This observation warrants further investigation.

Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations.

PURPOSE: To compare the effectiveness of topical and subconjunctival anesthesia in intravitreal injection administrations. METHODS: Twenty-eight patients from a university clinic with bilateral diabetic macular edema were prospectively randomized to receive intravitreal injection of 4 mg triamcinolone under topical anesthesia for one eye and subconjunctival anesthesia for the other eye by using lidocaine 4%. Patients were asked to grade the pain they experienced during administration of both anesthesia and intravitreal injection by using a 4-point pain scale: from 0=no pain to 3=severe pain. Complications that developed during both procedures were recorded. RESULTS: The mean pain score experienced during subconjunctival injections was 0.78+/-0.62, whereas no anesthesia-related pain was reported in the topical group. The mean pain score experienced during intravitreal injection was 1.64+/-0.67 in the topical and 0.85+/-0.52 in the subconjunctival group (p<0.001). The mean total pain scores of both procedures were 0.82+/-0.34 in the topical and 0.82+/-0.51 in the subconjunctival group (p>0.05). Nine eyes (32%) developed subconjunctival haemorrhage after subconjunctival injection, whereas no anesthesia-related complication developed in the topical group. Subconjunctival haemorrhage was also observed in 5 eyes (18%) in the topical group and in 11 eyes (40%) in the subconjunctival group (p>0.05) after intravitreal injection. CONCLUSIONS: Although subconjunctival anesthesia provides better pain control during intravitreal injections, its application is more painful and leads to subconjunctival haemorrhage. Moreover, the mean total pain scores are similar in both methods. Therefore, topical anesthesia may be more suitable for daily practice.