Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration

Completed · Phase 1

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID: NCT05643118
Run by: Olix Pharmaceuticals, Inc.
People needed: 21
Starts: 2023-01-04
Expected to finish: 2025-11-10
Last updated by the study team: 2025-12-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)
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

Where it is running

California Retina Consultants — Santa Maria, California, United States
University Retina — Oak Forest, Illinois, United States
The Retina Institute — St Louis, Missouri, United States
Ophthalmic Consultants of the Capital Region — Troy, New York, United States
Texas Retina Consultants — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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