OCU-10-C-110 Injection for Age-Related Macular Degeneration
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Ocugenix Corporation
Must be taking: Anti-VEGF
Disqualifiers: Cardiovascular, Cancer, Dementia, others
No Placebo Group
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.
12345Eligibility 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.
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Cohort B - Dose TBDExperimental Treatment1 Intervention
Group II: Cohort A - Dose 3Experimental Treatment1 Intervention
Group III: Cohort A - Dose 2Experimental Treatment1 Intervention
Group IV: Cohort A - Dose 1Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Retina Research Institute of TexasAbilene, TX
Raj K. Maturi, M.D., P.C.Carmel, IN
Strategic Clinical Research Group LLCWillow Park, TX
Strategic Clinical Research Group LLCAbilene, TX
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Who Is Running the Clinical Trial?
Ocugenix CorporationLead Sponsor
References
Intravitreal triamcinolone acetonide in exudative age-related macular degeneration. [2022]To examine the effects of intravitreal injection of 4.0 mg triamcinolone acetonide on the visual and clinical course of exudative age-related macular degeneration.
Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. [2022]Age-related macular degeneration (AMD) is one of the leading causes of permanent blindness worldwide. The current mainstay of treatment for neovascular AMD (nAMD) is intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents: aflibercept, ranibizumab, and off-label bevacizumab. Injections can be given monthly, every two or three months ('extended-fixed'), or as needed (pro re nata (PRN)). A variant of PRN is 'treat-and-extend' whereby injections are resumed if recurrence is detected and then delivered with increasing intervals. Currently, injection frequency varies among practitioners, which underscores the need to characterize an optimized approach to nAMD management.
Three-year outcome of aflibercept treatment for Japanese patients with neovascular age-related macular degeneration. [2021]To evaluate the three-year outcome after intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration (nAMD).
Anecortave acetate. [2019]This manuscript reviews the pharmacotherapeutics of the novel, angiostatic cortisene, anecortave acetate suspension, for the treatment of age-related macular degeneration. The chemistry, pharmacokinetics and pharmacodynamics of anecortave acetate are discussed, and the results of the multi-centre, randomised, controlled clinical trials for the treatment of subfoveal choroidal neovascularisation in age-related macular degeneration summarised. It also discusses ongoing clinical trials involving anecortave acetate for dry and wet age-related macular degeneration.
Potential role of lampalizumab for treatment of geographic atrophy. [2020]The purpose of this article is to review the pathways underlying age-related macular degeneration and potential therapeutic targets, focusing on the complement pathway and the recent MAHALO Phase II trial of the investigational drug lampalizumab. This trial was the first to have shown positive results for the treatment of geographic atrophy in age-related macular degeneration. It has potential as a future treatment, and is currently undergoing a Phase III trial.