OCU-10-C-110 Injection for Age-Related Macular Degeneration

Recruiting at 3 trial locations

Overseen By Sean McDonald

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ocugenix Corporation

Must be taking: Anti-VEGF

Disqualifiers: Cardiovascular, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

19 Participants Needed

Trial Summary

What is the purpose of this trial?

Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD

Do I need to stop 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 an anti-VEGF injection in the study eye 7 to 14 days before the trial starts.

What data supports the effectiveness of the drug OCU-10-C-110 for age-related macular degeneration?

The research mentions the use of intravitreal injections (injections into the eye) of triamcinolone acetonide and anti-VEGF agents like aflibercept, which are treatments for age-related macular degeneration. These treatments have shown effectiveness in managing the condition, suggesting that similar injection-based therapies, like OCU-10-C-110, might also be effective. ^{1 2 3 4 5}

Research Team

Roger Goldberg, MD

Principal Investigator

Lexitas Pharma

Eligibility Criteria

This trial is for adults with active wet age-related macular degeneration (nAMD), confirmed by recent tests. Participants must have had an approved anti-VEGF eye injection within 7 to 14 days before starting the study.

Inclusion Criteria

I have a recent eye condition due to AMD causing abnormal blood vessels.

I received an eye injection for VEGF treatment 7-14 days ago.

Exclusion Criteria

I don't have any health issues that would make the study drug unsafe for me.

I have had eye surgery or issues like retinal detachment in the eye being studied.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single intravitreal dose in a single eye with dose escalation in 3 successive cohorts

8 weeks

3 visits (in-person)

Treatment Part B

Participants receive 3 treatments in a single eye at 4-week intervals of the maximally tolerated dose

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OCU-10-C-110 for Injection

Trial Overview The trial is testing OCU-10-C-110, a new medication given as an injection into the eye. It's conducted in multiple centers and involves initial single doses followed by repeated administration at the highest tolerated dose.

Participant Groups

Group I: Cohort B - Dose TBD Experimental Treatment 1 Intervention

Group II: Cohort A - Dose 3 Experimental Treatment 1 Intervention

Group III: Cohort A - Dose 2 Experimental Treatment 1 Intervention

Group IV: Cohort A - Dose 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ocugenix Corporation

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

A single intravitreal injection of 4.0 mg triamcinolone acetonide significantly improved visual acuity in patients with exudative age-related macular degeneration compared to untreated controls over a 6-month period.

While the treatment showed benefits in visual and clinical outcomes, 25% of patients experienced elevated intraocular pressure, and there was a higher incidence of cataract progression, indicating the need for careful monitoring and further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal triamcinolone acetonide in exudative age-related macular degeneration. Danis, RP., Ciulla, TA., Pratt, LM., et al.[2022]

Monthly injections of anti-VEGF agents for neovascular age-related macular degeneration (nAMD) are likely more effective than PRN regimens, with a small but significant difference in visual acuity improvement after one year, based on a review of 15 trials involving 7732 participants.

Monthly regimens are associated with a higher risk of endophthalmitis (8 in 1000 people per year) compared to PRN regimens (1 in 1000 people per year), suggesting that while monthly injections may offer better efficacy, they also come with increased safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Li, E., Donati, S., Lindsley, KB., et al.[2022]

In a study of 49 treatment-naïve patients with neovascular age-related macular degeneration (nAMD), intravitreal aflibercept injections led to significant visual improvement over three years, with mean logMAR scores improving from 0.42 at baseline to 0.26 at 36 months.

The treatment also resulted in substantial reductions in central retinal thickness and subfoveal choroidal thickness, indicating effective morphological changes; however, these improvements did not fully sustain the initial visual gains over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-year outcome of aflibercept treatment for Japanese patients with neovascular age-related macular degeneration. Itagaki, K., Sekiryu, T., Kasai, A., et al.[2021]

Anecortave acetate is a novel angiostatic cortisene being investigated for treating age-related macular degeneration, with a focus on its pharmacological properties and clinical trial results.

The manuscript summarizes findings from multi-centre, randomized controlled trials targeting subfoveal choroidal neovascularization, indicating its potential effectiveness in managing both dry and wet forms of age-related macular degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anecortave acetate. Bakri, SJ., Kaiser, PK.[2019]

The MAHALO Phase II trial demonstrated positive results for lampalizumab in treating geographic atrophy associated with age-related macular degeneration, marking a significant advancement in potential therapies for this condition.

Lampalizumab targets the complement pathway, which is a key factor in the progression of age-related macular degeneration, and is currently being evaluated in a Phase III trial for further efficacy and safety assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential role of lampalizumab for treatment of geographic atrophy. Rhoades, W., Dickson, D., Do, DV.[2020]

References

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

Intravitreal triamcinolone acetonide in exudative age-related macular degeneration. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Three-year outcome of aflibercept treatment for Japanese patients with neovascular age-related macular degeneration. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Anecortave acetate. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Potential role of lampalizumab for treatment of geographic atrophy. [2020]