Neovascular Age-related Macular DegenerationPhase 1NCT05643118
Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration
A Phase 1 study testing OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) in people with Neovascular Age-related Macular Degeneration, run by Olix Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Jan 2023to 10 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥50 years of age
- Primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea, as evidenced by FA in the study eye
- CNV must be ≥50% of the total lesion size in the study eye
- ETDRS BCVA score ranging from 20/60 to 20/400 in the study eye
- Clear ocular media and adequate pupillary dilation (able to dilate pupil to ≥4 mm using standard mydriatics) in the study eye to permit good stereoscopic fundus photography
- Retinal thickness ≥200 μm in the macular region of the study eye as measured by SD-OCT, and active neovascular AMD, in the opinion of the Investigator
- Willing, committed, and able to return for all clinic visits and complete all study-related procedures
- Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or by a family member), understand, and willing to sign the informed consent form
Who cannot join
- Any prior systemic treatment for neovascular AMD in either eye, except dietary supplements or vitamins or systemic anti-VEGF therapy, or planned use at any time during the study
- Any prior treatment in the study eye with another investigational agent to treat neovascular AMD within 6 months prior to Day 0 or planned use at any time during the study
- Prior treatment with anti-VEGF agents as follows:
- Anti-VEGF therapy in the study eye within 4 weeks prior to Day 0
- Anti-VEGF therapy in the study eye at any time to which there was no response, as defined by the presence of at least 1 of the following conditions: (1) persistent (plasma) fluid exudation, (2) unresolved or new hemorrhage, and (3) progressive lesion fibrosis
- Anti-VEGF therapy in the fellow eye with an investigational agent (not FDA approved, unless it is bevacizumab) within 3 months prior to Day 0 (prior treatment with an FDA approved anti-VEGF therapy in the fellow eye is allowed at any time)
Show all 29Show fewer
- Systemic anti-VEGF therapy, investigational or FDA approved, within 3 months prior to Day 0 or planned use at any time during the study
- Scar or fibrosis in the study eye involving >50% of the total lesion size
- Retinal pigment epithelial tears or rips in the study eye involving the macula within 6 months prior to Day 0
- History of any vitreous hemorrhage in the study eye within 4 weeks prior to Day 0
- Presence of other causes of CNV in the study eye, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis
- Clinical evidence of moderate or severe diabetic retinopathy, diabetic macular edema, or any other inflammatory or occlusive vascular disease affecting the retina (other than AMD) in either eye
- History of stage ≥2 macular hole in the study eye
- Any prior intraocular or periocular surgery on the study eye within 3 months prior to Day 0 (lid surgery is allowed if it took place at least 1 month prior to Day 0 and is unlikely to interfere with OLX10212 injection). Prior vitrectomy in the study eye, surgery for retinal detachment in the study eye, and prior trabeculectomy or other filtration surgery in the study eye are not permitted at any time
- Uncontrolled glaucoma (defined as IOP ≥25 mmHg despite treatment with antiglaucoma medication) in the study eye
- Glaucoma in the study eye requiring treatment with 3 or more antiglaucoma medications
- Active intraocular inflammation or history of uveitis in either eye
- Presence or history of ocular or periocular infection in either eye within 2 weeks prior to Day 0
- Presence of scleromalacia in the study eye
- Aphakia or absence of posterior capsule in the study eye (unless due to yttrium aluminum garnet [YAG] posterior capsulotomy)
- Prior therapeutic radiation in the region of the study eye or planned use at any time during the study
- Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could interfere with visual acuity, assessment of safety, or fundus photography
- Any concurrent intraocular condition in the study eye (eg, cataract) that, in the opinion of the Investigator, could (1) require either medical or surgical intervention during the 24- or 32-week study period (Part A or Part B, respectively), (2) increase the risk to the patient beyond what is to be expected from standard intraocular injection procedures, or (3) otherwise interfere with the injection procedure or efficacy or safety evaluation
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
- Participation as a patient in any clinical study or prior systemic or ocular treatment with an investigational agent within 12 weeks prior to Day 0
- Prior systemic or intraocular treatment with long-acting steroids within 6 months prior to Day 0 or planned use at any time during the study
- History of allergy to povidone iodine
- Known allergy to fluorescein sodium for injection in angiography
- Unwillingness among females who are pregnant, breastfeeding, or of childbearing potential to practice adequate contraception throughout the study. Adequate contraceptive measures include oral contraceptives (stable use for ≥2 cycles prior to Day 0), intrauterine device, Depo-Provera® (Pfizer, Inc., New York) or Norplant System® (Pfizer, Inc., New York) implants, bilateral tubal ligation, vasectomy, and condom or diaphragm plus contraceptive sponge, foam, or jelly. A female is considered to be of childbearing potential unless she is premenstrual, 1 year postmenopausal, or 3 months post-surgical sterilization. All females of childbearing potential, including those with post-tubal ligation, must have a negative urine pregnancy test result at Day 0 and every 4 weeks as outlined in the Schedule of Activities. A negative serum pregnancy test must be obtained at Screening.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Texas Retina Consultants
Bellaire, Texas, 77401
University Retina
Oak Forest, Illinois, 60452
California Retina Consultants
Santa Maria, California, 93434
The Retina Institute
St Louis, Missouri, 63128
Ophthalmic Consultants of the Capital Region
Troy, New York, 12180
About this study
Official title: Evaluation of the Safety and Tolerability of OLX10212 in Patients With Neovascular Age-Related Macular Degeneration
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.
Read the detailed description
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose escalation study to evaluate the safety, tolerability, and preliminary efficacy of OLX10212 in the treatment of age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, i.e. participants will receive one intravitreal injection of OLX10212 at different dose levels and Part B is a multiple ascending dose study, i.e. participants will receive up to three intravitreal injections of OLX10212. Up to 42 individuals with AMD will be invited to participate in this study. The mechanism of action of OLX10212 holds promise to treat AMD by improving inflammation in the retina which is typically observed in patients with AMD. This is the first time OLX10212 is used in patients with AMD. Safety and tolerability of OLX10212 will be assessed via detailed ophthalmologic evaluations, vital signs, and clinical laboratory testing. In addition, plasma concentrations of OLX10212 will be measured and evaluations of the therapeutic effects of OLX10212 will be performed.
Part A uses a dose-ascending, sequential design to evaluate up to five doses of OLX10212, starting with the lowest dose of OLX10212 in a 50-μL injection. Up to six patients will be enrolled at each dose level. Each of the enrolled patients will receive a single intravitreal administration of OLX10212. The safety and tolerability evaluation period will encompass the first 14 days following OLX10212 administration. The effects of OLX10212 will be observed up to 24-weeks after injection. Based on the safety and tolerability evaluation, a decision will be made whether or not to increase the dose to the next higher dose levels for the subsequent patient cohorts. Therefore, a total of up to 30 patients (up to 5 dose levels and up to 6 patients/dose level) will be enrolled in Part A of this study.
Part B of this study uses a dose-ascending, sequential design to evaluate 2 dose levels of OLX10212 (750 and 950 μg/eye/50 μL), starting with the 750 μg/eye/50 μL dose. Three patients will initially be enrolled in each cohort. Each of the enrolled patients will receive a total of up to three intravitreal injections of OLX10212, each four weeks apart (Week 0, Week 4, and Week 8). The DLT evaluation period will encompass the first 10 weeks following the first OLX10212 administration (ending 2 weeks following the third OLX10212 administration), during which safety and tolerability will be assessed at each visit. In addition, the plasma concentrations of OLX10212 will be measured and therapeutic effects will be evaluated. A total of up to 12 patients with AMD (3 dose levels and up to 6 patients/dose level) will be invited to participate in Part B of this study.
- Being tested
- OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)
- Keywords
- Neovascular age-related macular degeneration, OLX10212, siRNA, intravitreal injection, safety and tolerability, preliminary efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)Genetic
Also called OLX10212
Clear colorless solution dissolved in 1X PBS and injected intravitreally
| Study group | Role | What they receive |
|---|---|---|
| Part A 100 μg/eye/50 μL | Experimental | study eye treated with 100 μg (94.3 μg free acid) of OLX10212 Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part A 250 μg/eye/50 μL | Experimental | study eye treated with 250 μg (235.8 μg free acid) of OLX10212 Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part A 500 μg/eye/50 μL | Experimental | study eye treated with 500 μg (471.5 μg free acid) of OLX10212 Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part A 750 μg/eye/50 μL | Experimental | study eye treated with 750 μg (707.3 μg free acid) of OLX10212 Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part A 950 μg/eye/50 μL | Experimental | study eye treated with 950 μg (895.9 μg free acid) of OLX10212 Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part B 750 μg/eye/50 μL | Experimental | study eye treated with a total of 3 intravitreal injections of 750 μg (707.3 μg free acid) of OLX10212 each 28 days apart Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
| Part B 950 μg/eye/50 μL | Experimental | study eye treated with a total of 3 intravitreal injections of 950 μg (895.9 μg free acid) of OLX10212 each 28 days apart Receives: Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
Visual acuity using an ETDRS chart
Measured: 28 days after last dose administration
Intraocular pressure (IOP)
Millimeters of mercury (mmHg)
Measured: 28 days after last dose administration
Slit lamp
Anterior segment of the eye examination
Measured: 28 days after last dose administration
Fundus examination
Posterior segment of the eye examination
Measured: 28 days after last dose administration
Spectral-domain optical coherence tomography (SD-OCT)
Evaluation of retinal characteristics
Measured: 28 days after last dose administration
Fluorescein angiography (FA)
Evaluation of retinal vasculature
Measured: 28 days after last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start4 Jan 2023
- Primary completion25 Nov 2024
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trial Runners, LLC, Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Toni Bransford, MD, Study director, Olix Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643118
- Sponsor's protocol ID
- OLX10212-01
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.
PubMed 27427487
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Tolerability of OLX10212 in Patients With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05643118
- Acronym / sponsor ID
- OLX10212-01
- Keywords
- Neovascular age-related macular degeneration, OLX10212, siRNA, intravitreal injection, safety and tolerability, preliminary efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Olix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Trial Runners, LLC, Avance Clinical Pty Ltd.
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, and Part B is a multiple ascending dose study. The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD. The exploratory objectives are to evaluate the preliminary efficacy of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD, and to evaluate the pharmacokinetics (PK) of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.
Detailed description
This is a Phase 1, multicenter, open-label, single- and multi-dose, dose escalation study to evaluate the safety, tolerability, and preliminary efficacy of OLX10212 in the treatment of age-related macular degeneration (AMD). This study is composed of 2 parts: Part A and Part B. Part A is a single ascending dose study, i.e. participants will receive one intravitreal injection of OLX10212 at different dose levels and Part B is a multiple ascending dose study, i.e. participants will receive up to three intravitreal injections of OLX10212. Up to 42 individuals with AMD will be invited to participate in this study. The mechanism of action of OLX10212 holds promise to treat AMD by improving inflammation in the retina which is typically observed in patients with AMD. This is the first time OLX10212 is used in patients with AMD. Safety and tolerability of OLX10212 will be assessed via detailed ophthalmologic evaluations, vital signs, and clinical laboratory testing. In addition, plasma concentrations of OLX10212 will be measured and evaluations of the therapeutic effects of OLX10212 will be performed.
Part A uses a dose-ascending, sequential design to evaluate up to five doses of OLX10212, starting with the lowest dose of OLX10212 in a 50-μL injection. Up to six patients will be enrolled at each dose level. Each of the enrolled patients will receive a single intravitreal administration of OLX10212. The safety and tolerability evaluation period will encompass the first 14 days following OLX10212 administration. The effects of OLX10212 will be observed up to 24-weeks after injection. Based on the safety and tolerability evaluation, a decision will be made whether or not to increase the dose to the next higher dose levels for the subsequent patient cohorts. Therefore, a total of up to 30 patients (up to 5 dose levels and up to 6 patients/dose level) will be enrolled in Part A of this study.
Part B of this study uses a dose-ascending, sequential design to evaluate 2 dose levels of OLX10212 (750 and 950 μg/eye/50 μL), starting with the 750 μg/eye/50 μL dose. Three patients will initially be enrolled in each cohort. Each of the enrolled patients will receive a total of up to three intravitreal injections of OLX10212, each four weeks apart (Week 0, Week 4, and Week 8). The DLT evaluation period will encompass the first 10 weeks following the first OLX10212 administration (ending 2 weeks following the third OLX10212 administration), during which safety and tolerability will be assessed at each visit. In addition, the plasma concentrations of OLX10212 will be measured and therapeutic effects will be evaluated. A total of up to 12 patients with AMD (3 dose levels and up to 6 patients/dose level) will be invited to participate in Part B of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A 100 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with 100 μg (94.3 μg free acid) of OLX10212 |
| Part A 250 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with 250 μg (235.8 μg free acid) of OLX10212 |
| Part A 500 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with 500 μg (471.5 μg free acid) of OLX10212 |
| Part A 750 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with 750 μg (707.3 μg free acid) of OLX10212 |
| Part A 950 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with 950 μg (895.9 μg free acid) of OLX10212 |
| Part B 750 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with a total of 3 intravitreal injections of 750 μg (707.3 μg free acid) of OLX10212 each 28 days apart |
| Part B 950 μg/eye/50 μL | Experimental | Genetic: OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)study eye treated with a total of 3 intravitreal injections of 950 μg (895.9 μg free acid) of OLX10212 each 28 days apart |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women ≥50 years of age
- Primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea, as evidenced by FA in the study eye
- CNV must be ≥50% of the total lesion size in the study eye
- ETDRS BCVA score ranging from 20/60 to 20/400 in the study eye
- Clear ocular media and adequate pupillary dilation (able to dilate pupil to ≥4 mm using standard mydriatics) in the study eye to permit good stereoscopic fundus photography
Key exclusion criteria (29 listed)
- Any prior systemic treatment for neovascular AMD in either eye, except dietary supplements or vitamins or systemic anti-VEGF therapy, or planned use at any time during the study
- Any prior treatment in the study eye with another investigational agent to treat neovascular AMD within 6 months prior to Day 0 or planned use at any time during the study
- Prior treatment with anti-VEGF agents as follows:
- Scar or fibrosis in the study eye involving >50% of the total lesion size
- Retinal pigment epithelial tears or rips in the study eye involving the macula within 6 months prior to Day 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA)Also: OLX10212Clear colorless solution dissolved in 1X PBS and injected intravitreally | Genetic | Part A 100 μg/eye/50 μL, Part A 250 μg/eye/50 μL, Part A 500 μg/eye/50 μL, Part A 750 μg/eye/50 μL, Part A 950 μg/eye/50 μL, Part B 750 μg/eye/50 μL, Part B 950 μg/eye/50 μL |
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: 28 days after last dose administration
Visual acuity using an ETDRS chart
Intraocular pressure (IOP)
Time frame: 28 days after last dose administration
Millimeters of mercury (mmHg)
Slit lamp
Time frame: 28 days after last dose administration
Anterior segment of the eye examination
Fundus examination
Time frame: 28 days after last dose administration
Posterior segment of the eye examination
Spectral-domain optical coherence tomography (SD-OCT)
Time frame: 28 days after last dose administration
Evaluation of retinal characteristics
Fluorescein angiography (FA)
Time frame: 28 days after last dose administration
Evaluation of retinal vasculature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 27427487Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toni Bransford, MD study director
Olix Pharmaceuticals, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OLX10212 is a cell penetrating asymmetric small interference RNA (cp-asiRNA) in people with Neovascular Age-related Macular Degeneration, run by Olix Pharmaceuticals, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) (time frame: 28 days after last dose administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.