scholarly journals Nerve growth factor eye drops improve visual acuity and electrofunctional activity in age-related macular degeneration: a case report

2009 ◽  
Vol 45 (4) ◽  
Author(s):  
Alessandro Lambiase ◽  
Marco Coassin ◽  
Paola Tirassa ◽  
Flavio Mantelli ◽  
Luigi Aloe
Keyword(s):  
Visual Acuity ◽  
Case Report ◽  
Nerve Growth Factor ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Eye Drops ◽  
Nerve Growth ◽  
Age Related

APEX: a phase II randomised clinical trial evaluating the safety and preliminary efficacy of oral X-82 to treat exudative age-related macular degeneration

2020 ◽  
pp. bjophthalmol-2020-316511
Author(s):  
Michael N. Cohen ◽  
Denis O’Shaughnessy ◽  
Kate Fisher ◽  
Jennifer Cerami ◽  
Carl C Awh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Acuity ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Age Related Macular Degeneration ◽  
Anti Vegf ◽  
Age Related ◽  
Dose Dependent

PurposeThe safety and efficacy of X-82, an orally administered inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor, was investigated for treatment of wet age-related macular degeneration (AMD) in a phase II clinical trial.MethodsThis phase II, randomised, double-masked, placebo-controlled trial enrolled subjects with a prior diagnosis of exudative AMD having received at least two intravitreal injections of anti-VEGF therapy. Subjects were randomised equally into four groups that received either daily 50mg, 100mg or 200mg dosages of X-82 or a placebo tablet. At each 4-week interval visit for 52 weeks, subjects were to be assessed to determine if rescue treatment was needed with anti-VEGF therapy.Results157 patients were enrolled. Due to gastrointestinal and hepatobiliary adverse events and the fulfilment of the primary endpoint, the trial was stopped prematurely after a second interim analysis. The primary endpoint of non-inferiority of visual acuity compared with placebo was demonstrated in all groups receiving X-82 (p<0.001). There was a dose-dependent trend in the number of injections over a 52-week period, with the 50 mg (n=40), 100 mg (n=39), 200 mg (n=39) and placebo (n=39) group requiring 6.7, 6.0, 4.7 and 8.1 injections, respectively.ConclusionsX-82 oral therapy in combination with pro re nata anti-VEGF injections showed non-inferiority in visual acuity outcomes while achieving a dose-dependent decrease in the number of anti-VEGF injections compared with placebo. Given the limited tolerability and safety issues observed, X-82 does not have a sufficient benefit to risk profile in treatment of patients with AMD.

scholarly journals Long-term Outcomes of Treat and Extend Regimen of Anti-vascular Endothelial Growth Factor in Neovascular Age-related Macular Degeneration

2020 ◽  
Author(s):  
Andy Lee ◽  
Pooja G Garg ◽  
Alice T Lyon ◽  
Rukhsana Mirza ◽  
Manjot K Gill
Keyword(s):  
Visual Acuity ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Final Visit ◽  
Treat And Extend ◽  
Age Related ◽  
Endothelial Growth Factor

Purpose: This study describes the long-term visual and anatomic outcomes of antivascular endothelial growth factor (VEGF) treatment using a treat and extend dosing regimen. Methods: This cross-sectional cohort study consisted of 224 treatment-naïve eyes with neovascular age-related macular degeneration (NV-AMD) from 202 patients that were treated with anti-VEGF agents bevacizumab, ranibizumab, and aflibercept using a treat and extend (TAE) regimen by four physician investigators in a large urban referral center from 2008 to 2015. Subjects were evaluated for visual acuity, injection frequency, and optical coherence tomography (OCT). Results: Over a seven-year follow-up period (mean 3.4 years), an average 20.2 ± 14.7 injections were administered with 8.4 injections in the first year and 5.5 injections by the seventh year of remaining eyes undergoing treatment. Visual acuity was 0.70 logMAR (20/100 Snellen) at the first visit and 0.67 logMAR (20/93 Snellen) at the final visit, with 74% of eyes maintaining or gaining more than 2 lines of vision. Long-term, 45.1% of eyes achieved 20/50 or better, while 27.1% were 20/200 or worse. Of the treated patients, 61.2% received monotherapy with no difference in visual acuity outcomes or number of injections between the agents used. OCT analysis showed decreased fluid from initial to final follow-up visit: 70.1–15.6% with sub-retinal fluid (SRF) and 47.3–18.8% with intraretinal fluid (IRF) with no difference between the agents were used. Conclusion: This study demonstrates that most patients (74%) improve or maintain visual acuity long-term using a TAE model with a significant portion (45.1%) achieving 20/50 or better visual acuity with sustained treatment.

scholarly journals Nerve Growth Factor-Based Therapy in Alzheimer’s Disease and Age-Related Macular Degeneration

2021 ◽  
Vol 15 ◽  
Author(s):  
Giuseppina Amadoro ◽  
Valentina Latina ◽  
Bijorn Omar Balzamino ◽  
Rosanna Squitti ◽  
Monica Varano ◽  
...  
Keyword(s):  
Nerve Growth Factor ◽  
Trace Metals ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Tau Protein ◽  
Basal Forebrain ◽  
Cholinergic Neurons ◽  
Age Related Macular Degeneration ◽  
Retinal Ganglion ◽  
Age Related

Alzheimer’s disease (AD) is an age-associated neurodegenerative disease which is the most common cause of dementia among the elderly. Imbalance in nerve growth factor (NGF) signaling, metabolism, and/or defect in NGF transport to the basal forebrain cholinergic neurons occurs in patients affected with AD. According to the cholinergic hypothesis, an early and progressive synaptic and neuronal loss in a vulnerable population of basal forebrain involved in memory and learning processes leads to degeneration of cortical and hippocampal projections followed by cognitive impairment with accumulation of misfolded/aggregated Aβ and tau protein. The neuroprotective and regenerative effects of NGF on cholinergic neurons have been largely demonstrated, both in animal models of AD and in living patients. However, the development of this neurotrophin as a disease-modifying therapy in humans is challenged by both delivery limitations (inability to cross the blood–brain barrier (BBB), poor pharmacokinetic profile) and unwanted side effects (pain and weight loss). Age-related macular degeneration (AMD) is a retinal disease which represents the major cause of blindness in developed countries and shares several clinical and pathological features with AD, including alterations in NGF transduction pathways. Interestingly, nerve fiber layer thinning, degeneration of retinal ganglion cells and changes of vascular parameters, aggregation of Aβ and tau protein, and apoptosis also occur in the retina of both AD and AMD. A protective effect of ocular administration of NGF on both photoreceptor and retinal ganglion cell degeneration has been recently described. Besides, the current knowledge about the detection of essential trace metals associated with AD and AMD and their changes depending on the severity of diseases, either systemic or locally detected, further pave the way for a promising diagnostic approach. This review is aimed at describing the employment of NGF as a common therapeutic approach to AMD and AD and the diagnostic power of detection of essential trace metals associated with both diseases. The multiple approaches employed to allow a sustained release/targeting of NGF to the brain and its neurosensorial ocular extensions will be also discussed, highlighting innovative technologies and future translational prospects.

Review of Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration

2013 ◽  
Vol 5 ◽  
pp. CMT.S8921 ◽  
Author(s):  
Michael W. Stewart
Keyword(s):  
Visual Acuity ◽  
Growth Factor ◽  
Macular Degeneration ◽  
Vision Loss ◽  
Age Related Macular Degeneration ◽  
Vegf Inhibitors ◽  
Vegf Inhibitor ◽  
Age Related ◽  
Soluble Fusion Protein ◽  
Endothelial Growth Factor

The treatment of exudative age-related macular degeneration (AMD) has been completely transformed by the development of drugs that bind vascular endothelial growth factor (VEGF). The antibody-based VEGF inhibitors bevacizumab and ranibizumab usually prevent the enlargement of choroidal neovascular membranes, reduce vascular permeability, and improve visual acuity. The newest VEGF inhibitor, aflibercept, is a soluble fusion protein that binds all isoforms of VEGF-A, VEGF-B, and placental growth factor with high affinity. Preclinical studies demonstrated aflibercept's ability to prevent experimental neovascularization and tumor growth in animal models. In phase 3 trials for exudative AMD, patients who received aflibercept avoided moderate vision loss and experienced improved visual acuity comparable to those who received ranibizumab. Additionally, patients who were treated with aflibercept 2 mg every 8 weeks (after 3 monthly loading doses) had similar visual results to those treated every 4 weeks. When treated as needed during the second year of the trials, patients were able to last an average of 3 months between aflibercept injections. Since its regulatory approval, aflibercept has also been found to perform well as a salvage therapy for eyes that respond incompletely to ranibizumab and bevacizumab. Because aflibercept can be administered less frequently than ranibizumab, it promises to decrease the frequency of patients’ visits to physicians’ offices in addition to the overall cost of AMD therapy.

scholarly journals Safety and Effectiveness of Cataract Surgery with Simultaneous Intravitreal Anti-VEGF in Patients with Previously Treated Exudative Age-Related Macular Degeneration

2017 ◽  
Vol 30 (2) ◽  
pp. 127 ◽  
Author(s):  
Manuel Sousa Falcão ◽  
Paulo Freitas-Costa ◽  
João Nuno Beato ◽  
João Pinheiro-Costa ◽  
Amândio Rocha-Sousa ◽  
...  
Keyword(s):  
Vascular Endothelial Growth Factor ◽  
Visual Acuity ◽  
Growth Factor ◽  
Cataract Surgery ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Vascular Endothelial ◽  
Age Related ◽  
Previously Treated ◽  
Endothelial Growth Factor

Introduction: To evaluate the safety and impact on visual acuity, retinal and choroidal morphology of simultaneous cataract surgery and intravitreal anti-vascular endothelial growth factor on patients with visually significant cataracts and previously treated exudative age-related macular degeneration.Material and Methods: Prospective study, which included 21 eyes of 20 patients with exudative age-related macular degeneration submitted to simultaneous phacoemulsification and intravitreal ranibizumab or bevacizumab. The patients were followed for 12 months after surgery using a pro re nata strategy. Visual acuity, foveal and choroidal thickness changes were evaluated 1, 6 and 12 months post-operatively.Results: There was a statistically significant increase in mean visual acuity at one (13.4 letters, p < 0.05), six (11.5 letters, p < 0.05) and twelve months (11.3 letters, p < 0.05) without significant changes in retinal or choroidal morphology. At 12 months, 86% of eyes were able to maintain visual acuity improvement. There were no significant differences between the two anti-vascular endothelial growth factor drugs and no complications developed during follow-up.Discussion: Simultaneous phacoemulsification and intravitreal anti- vascular endothelial growth factor is safe and allows improvement in visual acuity in patients with visually significant cataracts and exudative age-related macular degeneration. Visual acuity gains were maintained with a pro re nata strategy showing that in this subset of patients, phacoemulsification may be beneficial.Conclusion: Cataract surgery and simultaneous anti-vascular endothelial growth factor therapy improves visual acuity in patients with exudative age-related macular degeneration.

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