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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injection called OCU-10-C-110 to determine its safety for individuals with age-related macular degeneration (AMD), a condition affecting eyesight. The researchers will administer varying doses to assess tolerance levels. Participants must have recently received eye injections for AMD and exhibit specific signs of the disease. The trial aims to identify the optimal use of the treatment for AMD patients. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that OCU-10-C-110 for Injection is likely to be safe for humans?

Research shows that OCU-10-C-110 for Injection may help treat age-related macular degeneration. However, earlier studies found that 25% of patients experienced increased pressure inside the eye. While the treatment might improve vision, higher eye pressure could pose a concern for some individuals. As a Phase 1 trial, the main goal is to assess the treatment's safety. At this stage, researchers are still learning about how well participants tolerate the treatment and what side effects might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

OCU-10-C-110 is unique because it offers a new approach to treating age-related macular degeneration (AMD). Unlike the standard treatments, such as anti-VEGF injections that primarily focus on reducing blood vessel growth in the eye, OCU-10-C-110 may target different biological pathways involved in AMD progression. This could potentially lead to improved outcomes for patients who don't respond well to current therapies. Researchers are excited about this treatment because it could expand the arsenal of options for managing AMD, offering hope for better vision preservation.

What evidence suggests that OCU-10-C-110 for Injection might be an effective treatment for age-related macular degeneration?

Research has shown that OCU-10-C-110 for Injection may help individuals with neovascular age-related macular degeneration (nAMD) see better. Early results suggest it could improve vision. However, approximately 25% of patients experienced increased eye pressure, which requires monitoring. This trial tests the treatment in different doses across various cohorts to determine the safest and most effective option. Although more information is needed, these early findings offer hope for improving vision in people with nAMD. ^{3 6 7 8 9}

Who Is on the Research Team?

Roger Goldberg, MD

Principal Investigator

Lexitas Pharma

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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A Phase 1 interventional study of OCU-10-C-110 in neovascular age-related macular degeneration ; Retina Research Institute of Texas Abilene, Texas, United States.