AIV007 for Age-Related Macular Degeneration/Diabetic Macular Edema
(DME Trial)
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AiViva BioPharma, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have received anti-VEGF treatment at least 6 weeks before the trial and cannot participate if you've been in another investigational study within 60 days before screening.
What data supports the idea that AIV007 for Age-Related Macular Degeneration/Diabetic Macular Edema is an effective treatment?
The available research does not provide specific data on AIV007 for Age-Related Macular Degeneration or Diabetic Macular Edema. Instead, it discusses other treatments like anti-VEGF drugs, which are commonly used for these conditions. These drugs have shown to help maintain or improve vision in patients with neovascular age-related macular degeneration. However, the research highlights the need for new treatments due to some patients not responding well or developing tolerance to current options. Therefore, while AIV007 might be promising, the provided information does not include specific evidence of its effectiveness.12345
What safety data is available for AIV007 treatment?
The provided research does not specifically mention AIV007 or AIV 007. However, it discusses the safety of anti-VEGF drugs, which are used in treating age-related macular degeneration and diabetic macular edema. These drugs, such as bevacizumab, ranibizumab, and aflibercept, have been associated with ocular adverse events like infection, inflammation, increased intraocular pressure, and vitreous hemorrhage. The studies highlight the importance of considering a patient's medical condition to minimize adverse events.678910
Is the drug AIV007 a promising treatment for Age-Related Macular Degeneration and Diabetic Macular Edema?
The drug AIV007 is considered promising because it is being studied for its potential to help people with Age-Related Macular Degeneration and Diabetic Macular Edema, which are conditions that can lead to vision loss. Although the specific benefits of AIV007 are not detailed in the provided research, the focus on these conditions suggests that AIV007 could offer new hope for improving or maintaining vision in affected individuals.12111213
Eligibility Criteria
This trial is for adults aged 21-90 with diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD). Participants must have had previous anti-VEGF treatments and show responsiveness. Exclusions include uncontrolled eye pressure, severe myopia, recent ocular infections or inflammations, poorly controlled diabetes, and hypersensitivity to study treatment components.Inclusion Criteria
My condition responds to anti-VEGF treatment.
Subject must provide written informed consent before any study-related procedures are performed
I have diabetes and significant eye swelling affecting my vision.
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Exclusion Criteria
I haven't had eye infections or inflammation recently.
I have received treatments other than anti-VEGF injections for nAMD or DME in my study eye.
Uncontrolled IOP (> 25 mmHg)
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Treatment Details
Interventions
- AIV007 (Other)
Trial OverviewThe trial tests the safety and effectiveness of a gel suspension called AIV007 administered around the eye in patients with nAMD or DME. It aims to understand how long the drug's effects last and how it moves through the body after being given.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: AIV007 low doseExperimental Treatment1 Intervention
Periocular injection, low dose
Group II: AIV007 intermediate dose 4Experimental Treatment1 Intervention
Periocular injection, intermediate dose 4
Group III: AIV007 intermediate dose 3Experimental Treatment1 Intervention
Periocular injection, intermediate dose 3
Group IV: AIV007 intermediate dose 2Experimental Treatment1 Intervention
Periocular injection, intermediate dose 2
Group V: AIV007 intermediate dose 1Experimental Treatment1 Intervention
Periocular injection, intermediate dose 1
Group VI: AIV007 High doseExperimental Treatment1 Intervention
Periocular injection, high dose
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Retina-Vitreous AssociatesBeverly Hills, CA
Orange County RetinaSanta Ana, CA
Verum ResearchEugene, OR
Valley Retina InstituteMcAllen, TX
More Trial Locations
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Who Is Running the Clinical Trial?
AiViva BioPharma, Inc.Lead Sponsor
References
Long-Term Visual Outcomes in Neovascular Age-Related Macular Degeneration Eyes With Baseline Macular Atrophy on Anti-Vascular Endothelial Growth Factor Treatment. [2023]This study explores the connection between macular atrophy (MA) status at baseline and best visual acuity (BVA) after 5 to 7 years of anti-vascular endothelial growth factor (anti-VEGF) injections on eyes with neovascular age-related macular degeneration (nAMD).
Machine Learning to Predict Response to Ranibizumab in Neovascular Age-Related Macular Degeneration. [2023]Neovascular age-related macular degeneration (nAMD) shows variable treatment response to intravitreal anti-VEGF. This analysis compared the potential of different artificial intelligence (AI)-based machine learning models using OCT and clinical variables to accurately predict at baseline the best-corrected visual acuity (BCVA) at 9 months in response to ranibizumab in patients with nAMD.
Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial. [2022]Anti-vascular endothelial growth factor (VEGF) agents may provide a prophylactic effect in high-risk eyes with intermediate dry age-related macular degeneration (AMD) against conversion to exudative AMD (eAMD), lowering the risk of vision loss.
Real-World Vision in Age-Related Macular Degeneration Patients Treated with Single Anti-VEGF Drug Type for 1 Year in the IRIS Registry. [2019]The purpose of this study is to compare real-world visual acuity (VA) in patients with neovascular age-related macular degeneration (nAMD) treated with a single anti-vascular endothelial growth factor (VEGF) drug monotherapy for 1 year from the American Academy of Ophthalmology (AAO) Intelligent Research in Sight (IRIS) Registry.
Emerging therapies and their delivery for treating age-related macular degeneration. [2022]Age-related macular degeneration (AMD) is the most common cause of blindness in the Western world and is characterised in its latter stages by retinal cell death and neovascularisation and earlier stages with the loss of parainflammatory homeostasis. Patients with neovascular AMD (nAMD) are treated with frequent intraocular injections of anti-vascular endothelial growth factor (VEGF) therapies, which are not only unpopular with patients but carry risks of sight-threatening complications. A minority of patients are unresponsive with no alternative treatment available, and some patients who respond initially eventually develop a tolerance to treatment. New therapeutics with improved delivery methods and sustainability of clinical effects are required, in particular for non-neovascular AMD (90% of cases and no current approved treatments). There are age-related and disease-related changes that occur which can affect ocular drug delivery. Here, we review the latest emerging therapies for AMD, their delivery routes and implications for translating to clinical practice. LINKED ARTICLES: This article is part of a themed issue on Inflammation, Repair and Ageing. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.9/issuetoc.
Systemic safety of intravitreal anti-vascular endothelial growth factor agents in age-related macular degeneration. [2018]The purpose of review is to summarize the literature addressing nonocular adverse events in patients with neovascular age-related macular degeneration treated with intravitreal vascular endothelial growth factor (VEGF) inhibitors and to present possible mechanisms of effect.
Gene Therapy in Neovascular Age-related Macular Degeneration: Three-Year Follow-up of a Phase 1 Randomized Dose Escalation Trial. [2017]To assess the safety of rAAV.sFlt-1 subretinal injection in neovascular age-related macular degeneration (wet AMD) over 36 months.
Anti-vascular endothelial growth factor drugs safety and efficacy in ophthalmic diseases. [2021]Macular degeneration is the leading cause of blindness in developed countries. In the treatment of neovascular age-related macular degeneration, vascular endothelial growth factor (VEGF) has emerged as a key target for therapy. The intravitreal injection of anti-VEGF drugs has been widely employed to reduce the disease progression and improve the visual outcomes of the affected patients. However, each intravitreal inoculation poses a risk of several complications as infection, inflammation, endophthalmitis, intraocular inflammation, increase of intraocular pressure and vitreous hemorrhage. This short review evaluates the efficacy and the incidence of adverse drug reactions related to intravitreal administration of the main anti-VEGF drugs actually available: Bevacizumab, ranibizumab and aflibercept.
Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. [2022]To assess the ocular and systemic safety of intravitreal aflibercept injection (IAI) compared with controls in IAI trials in neovascular age-related macular degeneration (nAMD), macular edema following central retinal vein occlusion (MEfCRVO), macular edema following branch retinal vein occlusion (MEfBRVO), and diabetic macular edema (DME).
Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS). [2022]Background: The purpose of this study is to identify and characterize ocular adverse events (AEs) that are significantly associated with anti-VEGF drugs for treatment of neovascular age-related macular degeneration and compare the differences between each drug, and provide clinical reference. Methods: Ocular AEs submitted to the US Food and Drug Administration were analyzed to map the safety profile of anti-VEGF drugs. The Pharmacovigilance tools used for the quantitative detection of signals were reporting odds ratio and bayesian confidence propagation neural network. Results: A total of 10,608,503 AE reports were retrieved from FAERS, with 20,836 for ranibizumab, 19,107 for aflibercept, and 2,442 for brolucizumab between the reporting period of Q1, 2004 and Q3, 2021. We found and analyzed the different AEs with the strongest signal in each drug-ranibizumab-macular ischaemia (ROR = 205.27, IC-2SD = 3.70), retinal pigment epithelial tear (ROR = 836.54, IC-2SD = 7.19); aflibercept-intraocular pressure increased (ROR = 31.09, IC-2SD = 4.61), endophthalmitis (ROR = 178.27, IC-2SD = 6.70); brolucizumab-retinal vasculitis (ROR = 2930.41, IC-2SD = 7.47) and/or retinal artery occlusion (ROR = 391.11, IC-2SD = 6.10), dry eye (ROR = 12.48, IC-2SD = 2.88). Conclusion: The presence of AEs should bring clinical attention. The use of anti-VEGF drugs should be based on the patient's underlying or present medical condition to reduce any adverse event associated with the treatment.
Dry Age-Related Macular Degeneration: Distribution of Visual Acuity and Progression Risk in a Large Registry. [2023]Understanding the progression to geographic atrophy (GA) in late dry age-related macular degeneration (dAMD) can support development opportunities for dAMD treatments. We characterized dAMD by distribution of visual acuity (VA) categories and evaluated VA progression risk by disease stage.
Retinal Nerve Fiber Layer Thickness Changes in Age-Related Macular Degeneration Treated with Multiple Intravitreal Ranibizumab. [2018]The objective of this study was to investigate the effect of multiple intravitreal ranibizumab (IVR) injections on the retinal nerve fiber layer (RNFL) in neovascular age-related macular degeneration (nAMD).
Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. [2022]To characterize relationships between Consensus on Neovascular Age-Related Macular Degeneration Nomenclature (CONAN) Study Group classifications of macular neovascularization (MNV) and visual responses to ranibizumab in patients with neovascular age-related macular degeneration (nAMD).