To examine the outcomes of clinical trials and case studies that investigated the different dosing regimens used for the 3 intravitreal anti-vascular endothelial growth factor (VEGF) inhibitors that ...are available currently. The Comparisons of Age-Related Macular Degeneration (AMD) Treatments Trial (CATT) data are discussed briefly here and are reviewed in greater detail in a separate accompanying article.
Sustained improvement with the 2 most widely used anti-VEGF drugs, bevacizumab and ranibizumab, requires monthly visits, posing a difficulty for patients. Thus, there is a need to evaluate whether individualized treatment regimens may reduce patient burden and improve patient outcomes.
Review of clinical trials and case studies presented at recent medical conferences and published in peer-reviewed literature.
Numerous trials, including the Efficacy and Safety of Ranibizumab in Patients with Subfoveal Choroidal Neovascularization (CNV) Secondary to AMD, Prospective Optical Coherence Tomography Imaging of Patients with Neovascular AMD Treated with Intraocular Ranibizumab, Study of Ranibizumab in Patients with Subfoveal CNV Secondary to AMD, Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with CNV Secondary to AMD or Macular Edema Secondary to Retinal Vein Occlusion, Safety Assessment of Intravitreal Lucentis for AMD, and CATT, have evaluated alternatives to monthly dosing. Evidence suggests that either a treat-as-needed or, possibly, a treat-and-extend regimen provides a reasonable approach to monthly injections recommended for bevacizumab and ranibizumab, with the caveat that as yet, careful and ongoing surveillance remains a key feature of optical management.
Individualization of antiangiogenic treatment using data from clinical trials evaluating various dosing regimens against the patient's disease, lifestyle, and economic restrictions continues to evolve.
Vitreolysis for Vitreomacular Traction and Macular Holes
Intravitreal injection of a modified protease that targets components of the vitreomacular interface resolved vitreomacular traction and ...closed macular holes more often than did placebo, albeit with associated, mainly transient, ocular adverse events.
The human vitreous body is bounded posteriorly by the retina and is variably adherent to it. Collagen fibrils forming the posterior vitreous cortex are firmly attached at the macula, the central part of the retina where visual acuity is best, and are connected to its internal limiting membrane by means of a biochemical glue composed of proteoglycans, including laminin and fibrinectin.
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With aging, the gel-like vitreous progressively liquefies and vitreoretinal adhesions weaken, leading to separation of the vitreous from the retina, or posterior vitreous detachment.
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Vitreomacular adhesion is observed after partial posterior vitreous detachment, when a portion of . . .
To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) ...associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO).
A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO.
A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426).
The primary outcome measure for the pooled data from the 2 studies was time to achieve a > or =15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety.
After a single administration, the time to achieve a > or =15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P<0.001). The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P<0.001). The percentage of eyes with a > or =15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P< or =0.036). Improvement in mean BCVA was greater in both DEX implant groups compared with sham at all follow-up visits (P< or =0.006). Improvements in BCVA with DEX implant were seen in patients with BRVO and patients with CRVO, although the patterns of response differed. The percentage of DEX implant-treated eyes with intraocular pressure (IOP) of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery.
Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.
A salute to Team Shields Haller, Julia
Indian journal of ophthalmology,
12/2019, Letnik:
67, Številka:
12
Journal Article
Recenzirano
Odprti dostop
At Notre Dame, she performed with remarkable distinction in the classroom and on the basketball court, where she was one of the inaugural founders of Notre Dame's women's varsity basketball team. ...Following graduation, she went on to serve her alma mater at the highest level on the school's athletic advisory boards, as an honored speaker, and in 2005 became the first alumna to be presented with an honorary degree from Notre Dame. Dr. Shields matriculated in medical school at the University of Pittsburgh where she had a brilliant track record and was inspired to become an ophthalmologist, following in her older brother's footsteps not only in the profession but also at Wills Eye Hospital, where she came in 1984 – and the rest is history! Dr. Haller's honors include the American Academy of Ophthalmology (AAO) Lifetime Achievement Award, the Strittmatter Award, the Gertrude Pyron Award from the Retina Research Foundation/American Society of Retina Specialists, the Louis Braille Award from Associated Services for the Blind, the Heed Award from the Society of Heed Fellows, the Gass Medal from the Macula Society, the Crystal Apple Award of the ASRS, the Kreissig Award from EURETINA, the President's Award from Women in Ophthalmology, a Secretariat Award from the AAO, and the Rolex Achievement Award.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Phase 1 studies have shown potential benefit of gene replacement in RPE65-mediated inherited retinal dystrophy. This phase 3 study assessed the efficacy and safety of voretigene neparvovec in ...participants whose inherited retinal dystrophy would otherwise progress to complete blindness.
In this open-label, randomised, controlled phase 3 trial done at two sites in the USA, individuals aged 3 years or older with, in each eye, best corrected visual acuity of 20/60 or worse, or visual field less than 20 degrees in any meridian, or both, with confirmed genetic diagnosis of biallelic RPE65 mutations, sufficient viable retina, and ability to perform standardised multi-luminance mobility testing (MLMT) within the luminance range evaluated, were eligible. Participants were randomly assigned (2:1) to intervention or control using a permuted block design, stratified by age (<10 years and ≥10 years) and baseline mobility testing passing level (pass at ≥125 lux vs <125 lux). Graders assessing primary outcome were masked to treatment group. Intervention was bilateral, subretinal injection of 1·5 × 1011 vector genomes of voretigene neparvovec in 0·3 mL total volume. The primary efficacy endpoint was 1-year change in MLMT performance, measuring functional vision at specified light levels. The intention-to-treat (ITT) and modified ITT populations were included in primary and safety analyses. This trial is registered with ClinicalTrials.gov, number NCT00999609, and enrolment is complete.
Between Nov 15, 2012, and Nov 21, 2013, 31 individuals were enrolled and randomly assigned to intervention (n=21) or control (n=10). One participant from each group withdrew after consent, before intervention, leaving an mITT population of 20 intervention and nine control participants. At 1 year, mean bilateral MLMT change score was 1·8 (SD 1·1) light levels in the intervention group versus 0·2 (1·0) in the control group (difference of 1·6, 95% CI 0·72–2·41, p=0·0013). 13 (65%) of 20 intervention participants, but no control participants, passed MLMT at the lowest luminance level tested (1 lux), demonstrating maximum possible improvement. No product-related serious adverse events or deleterious immune responses occurred. Two intervention participants, one with a pre-existing complex seizure disorder and another who experienced oral surgery complications, had serious adverse events unrelated to study participation. Most ocular events were mild in severity.
Voretigene neparvovec gene replacement improved functional vision in RPE65-mediated inherited retinal dystrophy previously medically untreatable.
Spark Therapeutics.
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