Phase 3, Randomized, 20-Month Study of the Efficacy and Safety of Bimatoprost Implant in Patients with Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 2)

Objective- To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods- This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results- Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2–7.4, 6.5–7.8, and 6.1–6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. Conclusions- The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma

Klinische Papillenbeurteilung bei Glaukom

Glaucoma is defined as a progressive neuropathy of the optic nerve, characterized by specific changes of the optic disc, parapapillary region, and retinal nerve fiber layer. Characteristic glaucomatous changes of the optic disc, parapapillary region, and retinal nerve fiber layer are discussed and their ophthalmoscopic examination is described. A literature search in the PubMed database was conducted. A systematic step-by-step approach to a qualitative and quantitative ophthalmoscopic evaluation of the optic disc regarding glaucomatous damage is presented. A systematic, clinical, qualitative, and quantitative assessment of the optic disc can be performed with little effort and forms the basis for diagnosis and treatment of glaucoma

Glaukome durch erhöhten episkleralen Venendruck

BackgroundGlaucoma due to elevated episcleral venous pressure is arare and difficult to treat form of secondary open angle glaucoma.ObjectiveThe pathophysiology, clinical findings, differential diagnosis and treatment options are discussed. Radius-Maumenee syndrome, Sturge-Weber syndrome and carotid-cavernous sinus fistulas are covered in particular.Material and methodsAliterature search was conducted in the PubMed database.ResultsIn the course of the diagnostics potentially severe diseases, such as carotid-cavernous sinus fistulas have to be ruled out. Treatment is based on the therapy of the underlying disease. Anti-glaucomatous medicinal treatment is often insufficient. In the case of surgery the increased risk for severe complications has to be taken into account. Avariety of different surgical approaches have been reported in anumber of small case series.ConclusionGlaucoma due to elevated episcleral venous pressure can be idiopathic or secondary to another underlying disease. Although rare it should always be considered in the differential diagnosis. Treatment is challenging because of an increased risk for severe complications

Retinopathia solaris

Background Solar retinopathy refers to damage to the central macula caused by exposure to intense solar radiation, most frequently observed after a solar eclipse. Objective Description of the morphological changes in spectral domain optical coherence tomography (SD-OCT) and the clinical course in patients with acute solar retinopathy. Materials and methods The study included a retrospective analysis of 12 eyes from 7 patients with solar retinopathy after the partial solar eclipse on 20 March 2015. Best corrected visual acuity, fundus changes and SD-OCT findings were analyzed. Out of the 7 patients 5 underwent treatment with 1 mg prednisolone per kg body weight. Results The average age of the patients was 30.1 +/- 13.1 years. Best corrected visual acuity was 0.65 at initial presentation. In the acute stage all affected eyes showed a small yellowish lesion in the centre of the fovea in the fundoscopic examination. In SD-OCT the continuity of all layers in the foveola appeared disrupted. In the follow-up examination these changes were partially resolved. After 2 months SD-OCT revealed a small defect of the ellipsoid zone. In one patient the defect could not be shown due to slightly excentric imaging sections. Best corrected visual acuity increased to 0.97. Conclusion The SD-OCT is an appropriate tool to determine the exact localization of the site of damage and for follow-up examination in solar retinopathy. In the acute phase it shows a disruption of the continuity of all layers in the foveola. Despite good recovery of visual acuity a small central defect of the ellipsoid zone remains in the long term

Anti-VEGF-Therapie bei fibrovaskulärer und serös-vaskularisierter Pigmentepithelabhebung bei neovaskulärer AMD

Background Neovascular age-related macular degeneration (nAMD) is the most frequent cause of pigment epithelial detachment (PED). In the clinical routine the treatment of fibrovascular PED (fPED) and serous vascularized PED (svPED) with intravitreal vascular endothelial growth factor (VEGF) inhibitors has a restricted prognosis. Objective There are limited data on the long-term outcome of PED under anti-VEGF therapy. Therefore, this study recorded the course of treated PEDs in nAMD eyes over a period of 5 years. Methods All eyes with fPED or svPED that underwent anti-VEGF medication between 2006 and 2015 were retrospectively analyzed regarding the clinical course and the morphology seen on optical coherence tomography (OCT). The inclusion criteria were the detection of a PED on OCT, the angiographic verification of nAMD, a documented clinical history over 5 years and a good image quality. Results A total of 23 eyes from 22 patients met the inclusion criteria. After 5 years a significant deterioration of visual acuity (VA) was seen in all eyes (p = 0.007) and in the subgroup of cases with fPED (p = 0.045). In the eyes with svPED the decline of VA was not significant (p = 0.097). In the collective study group a statistically significant reduction of PED height (p = 0.006) and an increase of PED diameter was measured (p = 0.002). In the subgroup analysis the decrease of PED height and increase of PED diameter were significant for cases with svPED (p = 0.004, p = 0.013, respectively) but were not statistically significant for fPED eyes (height: p = 0.616; diameter: p = 0.097). In 17 (74%) eyes fibrosis or atrophy were seen on the final assessment of OCT images. Discussion After 5 years of anti-VEGF therapy for nAMD-associated PED the VA declined in half of the eyes and the OCT showed an unfavorable morphology in 3/4 of the cases. The average number of visits and injections was distinctly lower than in clinical trials and other real-life analyses. In summary, we observed an undertreatment with a worse functional and anatomical outcome in our clinical routine compared to other studies

Präoperative Therapieumstellung vor filtrierender Glaukomchirurgie

Background. The preoperative switch from local to systemic antiglaucomatous therapy and the additional application of local antiphlogistic drugs represents an important component of perioperative wound healing modulation within the framework of glaucoma filtration surgery. Objective. The aim of the present study was to compare the intraocular pressure (IOP) under a maximum local and oral antiglaucomatous therapy with or without additional application of local steroids. Methods. A retrospective clinical analysis of 121 consecutive patients who underwent primary trabeculectomy for open-angle glaucoma in 2013 and who attended the outpatient clinic at least 3 weeks before surgery was carried out. The patients were set on preoperative therapy as follows: continuation of the maximum local antiglaucomatous therapy (with or without local dexamethasone 1 mg/ml 3 times daily) or administration of 750 mg acetazolamide orally per day (with or without local steroids). Results. The switch to oral antiglaucomatous therapy led to a mean IOP rise of 3.14 mmHg which was short of statistical significance (p = 0.052). The additional administration of local steroids did not significantly influence the IOP (p = 0.218). Some patients with oral acetazolamide therapy and local steroid application showed large increases in IOP up to 30 mm Hg. Conclusion. The mean IOP rise of 3.14 mmHg 3 weeks after replacement of antiglaucomatous eye drops by acetazolamide was short of missing statistical significance and seems to be clinically negligible for this relatively short period. The advantages of a lower postoperative fibrotic activity have to be weighed up against this change in IOP. Surprisingly, the effect of administration of local steroids for 3 weeks was minor compared to the effect of the switch from local to oral antiglaucomatous medication. Individual major IOP increases under the preoperative therapy change should be taken into consideration