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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 11 12 13}

Research Team

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.

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)

Treatment Details

Interventions

• AIV007 (Other)

Trial Overview The 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

Group I: AIV007 low dose Experimental Treatment 1 Intervention

Periocular injection, low dose

Group II: AIV007 intermediate dose 4 Experimental Treatment 1 Intervention

Periocular injection, intermediate dose 4

Group III: AIV007 intermediate dose 3 Experimental Treatment 1 Intervention

Periocular injection, intermediate dose 3

Group IV: AIV007 intermediate dose 2 Experimental Treatment 1 Intervention

Periocular injection, intermediate dose 2

Group V: AIV007 intermediate dose 1 Experimental Treatment 1 Intervention

Periocular injection, intermediate dose 1

Group VI: AIV007 High dose Experimental Treatment 1 Intervention

Periocular injection, high dose

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Retina-Vitreous Associates Beverly Hills, CA

Orange County Retina Santa Ana, CA

Verum Research Eugene, OR

Valley Retina Institute McAllen, TX

More Trial Locations

Who Is Running the Clinical Trial?

AiViva BioPharma, Inc.

Lead Sponsor

Trials

6

Patients Recruited

90+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Visual Outcomes in Neovascular Age-Related Macular Degeneration Eyes With Baseline Macular Atrophy on Anti-Vascular Endothelial Growth Factor Treatment. Foster, MJ., Shaia, J., Maatouk, CM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine Learning to Predict Response to Ranibizumab in Neovascular Age-Related Macular Degeneration. Maunz, A., Barras, L., Kawczynski, MG., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial. Heier, JS., Brown, DM., Shah, SP., et al.[2022]

In a study of 13,859 patients with neovascular age-related macular degeneration treated with anti-VEGF drugs, all three medications (bevacizumab, ranibizumab, and aflibercept) showed similar improvements in visual acuity after one year of treatment.

Despite initial differences in visual acuity outcomes, after adjusting for various factors, there were no significant differences in the overall effectiveness of the three drugs, although bevacizumab had a higher percentage of patients achieving a ≥3-line improvement in vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Vision in Age-Related Macular Degeneration Patients Treated with Single Anti-VEGF Drug Type for 1 Year in the IRIS Registry. Rao, P., Lum, F., Wood, K., et al.[2019]

Age-related macular degeneration (AMD) is the leading cause of blindness in the Western world, particularly affecting patients with neovascular AMD (nAMD) who currently rely on frequent and invasive anti-VEGF injections, which can lead to complications and treatment tolerance.

There is a pressing need for new therapies, especially for non-neovascular AMD, which accounts for 90% of cases and lacks approved treatments, highlighting the importance of developing improved drug delivery methods and sustainable clinical effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging therapies and their delivery for treating age-related macular degeneration. Thomas, CN., Sim, DA., Lee, WH., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic safety of intravitreal anti-vascular endothelial growth factor agents in age-related macular degeneration. Dedania, VS., Bakri, SJ.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene Therapy in Neovascular Age-related Macular Degeneration: Three-Year Follow-up of a Phase 1 Randomized Dose Escalation Trial. Constable, IJ., Lai, CM., Magno, AL., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-vascular endothelial growth factor drugs safety and efficacy in ophthalmic diseases. Ventrice, P., Leporini, C., Aloe, JF., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. Kitchens, JW., Do, DV., Boyer, DS., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS). Ma, P., Pan, X., Liu, R., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry Age-Related Macular Degeneration: Distribution of Visual Acuity and Progression Risk in a Large Registry. Leng, T., Schwartz, J., Nimke, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal Nerve Fiber Layer Thickness Changes in Age-Related Macular Degeneration Treated with Multiple Intravitreal Ranibizumab. Sengul, EA., Artunay, O., Kumral, ET., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. Freund, KB., Staurenghi, G., Jung, JJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Long-Term Visual Outcomes in Neovascular Age-Related Macular Degeneration Eyes With Baseline Macular Atrophy on Anti-Vascular Endothelial Growth Factor Treatment. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Machine Learning to Predict Response to Ranibizumab in Neovascular Age-Related Macular Degeneration. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Real-World Vision in Age-Related Macular Degeneration Patients Treated with Single Anti-VEGF Drug Type for 1 Year in the IRIS Registry. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Emerging therapies and their delivery for treating age-related macular degeneration. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Systemic safety of intravitreal anti-vascular endothelial growth factor agents in age-related macular degeneration. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Gene Therapy in Neovascular Age-related Macular Degeneration: Three-Year Follow-up of a Phase 1 Randomized Dose Escalation Trial. [2017]

8. India pubmed.ncbi.nlm.nih.gov

Anti-vascular endothelial growth factor drugs safety and efficacy in ophthalmic diseases. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Review of Ocular and Systemic Safety Events with Intravitreal Aflibercept Injection in Randomized Controlled Trials. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Ocular adverse events associated with anti-VEGF therapy: A pharmacovigilance study of the FDA adverse event reporting system (FAERS). [2022]

11. England pubmed.ncbi.nlm.nih.gov

Dry Age-Related Macular Degeneration: Distribution of Visual Acuity and Progression Risk in a Large Registry. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Retinal Nerve Fiber Layer Thickness Changes in Age-Related Macular Degeneration Treated with Multiple Intravitreal Ranibizumab. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. [2022]