COMPLETED

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

Conditions

Neovascular Age-related Macular Degeneration OLX10212 siRNA intravitreal injection safety and tolerability preliminary efficacy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of the Safety and Tolerability of OLX10212 in Patients With Neovascular Age-Related Macular Degeneration

Quick Facts

Study Start:2023-01-04

Study Completion:2025-11-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05643118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men and women ≥50 years of age 2. Primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea, as evidenced by FA in the study eye 3. CNV must be ≥50% of the total lesion size in the study eye 4. ETDRS BCVA score ranging from 20/60 to 20/400 in the study eye 5. 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 6. 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 7. Willing, committed, and able to return for all clinic visits and complete all study-related procedures 8. 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	1. 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 2. 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 3. Prior treatment with anti-VEGF agents as follows: 1. Anti-VEGF therapy in the study eye within 4 weeks prior to Day 0 2. 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 3. 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) 4. Systemic anti-VEGF therapy, investigational or FDA approved, within 3 months prior to Day 0 or planned use at any time during the study 4. Scar or fibrosis in the study eye involving \>50% of the total lesion size 5. Retinal pigment epithelial tears or rips in the study eye involving the macula within 6 months prior to Day 0 6. History of any vitreous hemorrhage in the study eye within 4 weeks prior to Day 0 7. Presence of other causes of CNV in the study eye, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis 8. 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 9. History of stage ≥2 macular hole in the study eye 10. 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 11. Uncontrolled glaucoma (defined as IOP ≥25 mmHg despite treatment with antiglaucoma medication) in the study eye 12. Glaucoma in the study eye requiring treatment with 3 or more antiglaucoma medications 13. Active intraocular inflammation or history of uveitis in either eye 14. Presence or history of ocular or periocular infection in either eye within 2 weeks prior to Day 0 15. Presence of scleromalacia in the study eye 16. Aphakia or absence of posterior capsule in the study eye (unless due to yttrium aluminum garnet \[YAG\] posterior capsulotomy) 17. Prior therapeutic radiation in the region of the study eye or planned use at any time during the study 18. 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 19. 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 20. 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 21. 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 22. 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 23. History of allergy to povidone iodine 24. Known allergy to fluorescein sodium for injection in angiography 25. 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.

Inclusion Criteria

Exclusion Criteria

1. Men and women ≥50 years of age
2. Primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea, as evidenced by FA in the study eye
3. CNV must be ≥50% of the total lesion size in the study eye
4. ETDRS BCVA score ranging from 20/60 to 20/400 in the study eye
5. 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
6. 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
7. Willing, committed, and able to return for all clinic visits and complete all study-related procedures
8. 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

1. 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
2. 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
3. Prior treatment with anti-VEGF agents as follows:
1. Anti-VEGF therapy in the study eye within 4 weeks prior to Day 0
2. 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
3. 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)
4. Systemic anti-VEGF therapy, investigational or FDA approved, within 3 months prior to Day 0 or planned use at any time during the study
4. Scar or fibrosis in the study eye involving \>50% of the total lesion size
5. Retinal pigment epithelial tears or rips in the study eye involving the macula within 6 months prior to Day 0
6. History of any vitreous hemorrhage in the study eye within 4 weeks prior to Day 0
7. Presence of other causes of CNV in the study eye, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis
8. 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
9. History of stage ≥2 macular hole in the study eye
10. 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
11. Uncontrolled glaucoma (defined as IOP ≥25 mmHg despite treatment with antiglaucoma medication) in the study eye
12. Glaucoma in the study eye requiring treatment with 3 or more antiglaucoma medications
13. Active intraocular inflammation or history of uveitis in either eye
14. Presence or history of ocular or periocular infection in either eye within 2 weeks prior to Day 0
15. Presence of scleromalacia in the study eye
16. Aphakia or absence of posterior capsule in the study eye (unless due to yttrium aluminum garnet \[YAG\] posterior capsulotomy)
17. Prior therapeutic radiation in the region of the study eye or planned use at any time during the study
18. 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
19. 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
20. 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
21. 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
22. 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
23. History of allergy to povidone iodine
24. Known allergy to fluorescein sodium for injection in angiography
25. 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.

Contacts and Locations

Principal Investigator

Toni Bransford, MD

STUDY_DIRECTOR

Olix Pharmaceuticals, Inc.

Study Locations (Sites)

California Retina Consultants

Santa Maria, California, 93434

United States

University Retina

Oak Forest, Illinois, 60452

United States

The Retina Institute

St Louis, Missouri, 63128

United States

Ophthalmic Consultants of the Capital Region

Troy, New York, 12180

United States

Texas Retina Consultants

Bellaire, Texas, 77401

United States

Collaborators and Investigators

Sponsor: Olix Pharmaceuticals, Inc.

Toni Bransford, MD, STUDY_DIRECTOR, Olix Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-04

Study Completion Date2025-11-10

Study Record Updates

Study Start Date2023-01-04

Study Completion Date2025-11-10

Terms related to this study

Keywords Provided by Researchers

Neovascular age-related macular degeneration
OLX10212
siRNA
intravitreal injection
safety and tolerability
preliminary efficacy

Additional Relevant MeSH Terms

Neovascular Age-related Macular Degeneration