Clinical Trials

Call us today at (720) 713-1810 to inquire about clinical trial opportunities

Introducing Advanced Vision Research Institute

Since the Eye Care Center of Northern Colorado opened in 1969, our practitioners have been interested in the advancement of science and focused on offering the best patient care possible for all ocular conditions. We are now proud to announce the opening of Advanced Vision Research Institute. We are actively participating in clinical trials and providing access to medications and cutting-edge devices that would otherwise be unavailable to our patients.

Current Clinical Trials

RegenX Bio / RGX-314-3101

ClinicalTrials.gov Identifier: NCT05407636

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX 314 Gene Therapy in Participants with nAMD

Detailed Description

This is a phase 3, multicenter, partially masked, randomized (1:1:1), active-controlled, parallel arm study in participants with nAMD to investigate the efficacy and safety of two doses of RGX-314 administered as a single subretinal injection in the study eye. Participants in the control arm will receive aflibercept administered intravitreally in the study eye over 54 weeks. Randomization of participants will be stratified by the Randomization Visit (Week -2) ETDRS BCVA score (> 58 letters vs ≤ 58 letters).

Participants randomized to the RGX-314 arms will exit the study at Week 54. Participants randomized to the aflibercept control arm will be offered the opportunity at Week 54 to cross over to RGX-314 treatment if they meet key inclusion/exclusion criteria. Participants eligible for crossover will undergo a similar treatment and evaluation schedule as the original RGX-314 randomized participants and be assessed through Week 108. Participants in the control arm who are not eligible to cross over will also exit the study at Week 54.

Inclusion Criteria
  • Males or females aged ≥ 50 years and ≤ 89 years.
  • An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye.
  • Must have a diagnosis of CNV secondary to AMD in the study eye, have received anti-VEGF therapy prior to Screening Visit 1 and been responsive, along with fluid within the parafovea (3-mm center of the macula, based on the early treatment diabetic retinopathy grid) at Screening Visit 1.
  • Must be pseudophakic (at least 12 weeks post cataract surgery) in the study eye.
  • Participants who received ≥ 10 anti-VEGF injections in the 12 months prior to Screening
Exclusion Criteria
  • CNV or macular edema in the study eye secondary to any causes other than AMD.
  • Active or history of retinal detachment or current retinal tear in the study eye.
  • Study eye with nAMD diagnosed > 4 years from Screening Visit 1.
  • History of malignancy or hematologic malignancy that may compromise the immune a system requiring chemotherapy and/or radiation in the 5 years prior to Screening Visit 1. Localized basal cell carcinoma will be permitted.
  • Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg, diastolic BP > 100 mmHg) despite maximal medical treatment.
  • History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1. Yttrium aluminum garnet capsulotomy is permitted if performed > 10 weeks prior to the Screening Visit 1.
  • Prior corneal transplant in the study eye.

Genentech / GE43220

ClinicalTrials.gov Identifier: NCT05300724

A MULTICENTER, PROSPECTIVE, OBSERVATIONAL STUDY OF THE PROGRESSION OF INTERMEDIATE AGE-RELATED MACULAR DEGENERATION

Detailed Description

This is an observational natural history trial and therefore no specific drug therapy will be evaluated in this study. Rather, structural changes in imaging characteristics on multimodal imaging instruments will be followed over time, and their relationship with visual function parameters will be studied.

Inclusion Criteria
  • Age 50 and 95 years at time of signing Informed Consent Form
  • Visual acuity: BCVA letter score of 72 letters (Snellen equivalent of 20/40 or better) using ETDRS chart at starting distance of 4 m
  • High-risk intermediate AMD with more than one large drusen 125 m and AMD pigmentary abnormalities
  • No evidence of prior or active exudative MNV
Exclusion Criteria
  • Macular disease in either eye with subretinal deposits not typical of AMD (e.g., Malattia Leventinese, Sorsby fundus dystrophy, Alport syndrome, and choroidal

    nevus)

  • Pigmentary abnormalities of the retina in either eye not typical of AMD (e.g., due to

    myopia, pattern dystrophy, or chronic central serous retinopathy)

  • Atrophy in either eye due to causes other than AMD (e.g., monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
  • History of glaucoma-filtering surgery (trabeculectomy, valves, or minimally invasive glaucoma stents)
  • History of retinal pigment epithelium tear
  • History of retinal tear that involves the macula
  • History of retinal detachment
  • History of corneal transplant
  • Proliferative diabetic retinopathy in either eye 

Alexion / ALXN2040-GA-201

ClinicalTrials.gov Identifier: NCT05019521

A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Detailed Description
This is a dose-finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 4 weeks, a 104-week masked Treatment Period, followed by an Open-label Extension (OLE) Period starting at Week 104 and lasting for up to 1 year. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo. Safety will be monitored throughout the study.
Inclusion Criteria
  • Presentation of GA secondary to AMD in at least 1 eye.
  • Study eye must have the specified visual acuity (range of 84 to 4 letters; 20/20 to 20/800) using Early Treatment Diabetic Retinopathy Study charts at a starting distance of 4 meters.
  • GA area of 0.5 to 17.76 square millimeter (~0.25 to 7 disc area) per eye measured by FAF.
Exclusion Criteria
  • GA in either eye due to cause other than AMD.
  • Have previously received intravitreal anti-vascular endothelial growth factor injections in study eye.
  • Have previously received any complement/stem cell/gene therapy for any ophthalmological condition.
  • Previous participation in interventional clinical studies for treatment of drusen, nascent GA or GA (except vitamins or minerals) irrespective of route of administration (ocular or systemic) in either eye.
  • Presence of active ocular diseases in either eye that in the opinion of the Investigator compromises or confounds visual function or interferes with study assessments.
  • Known or suspected complement deficiency.
  • History or presence of any clinically relevant co-morbidities or any uncontrolled conditions.
  • Hypersensitivity to fluorescein sodium for injection, the investigational drug (danicopan) or any of its excipients.

Opthea / OPT-302-1004

ClinicalTrials.gov Identifier: NCT04757610

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

Brief Summary

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Inclusion Criteria
  • Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
  • An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
Exclusion Criteria
  • Any previous treatment for neovascular AMD.
  • Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
  • Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

Unity / UBX1325-02

ClinicalTrials.gov Identifier: NCT04857996

This is a Phase 2a Proof-of-Concept (POC) study. The study has enrolled approximately 62 patients that were randomized 1:1 into either the UBX1325 or sham study arms, in order to assess the primary objective(s). All patients are in a 24-week follow-up period.

This Study is currently closed for enrollment with patients remaining in followup care.

Detailed Description

This is a Phase 2a Proof-of-Concept (POC) study. The study will enroll approximately 62 patients randomized 1:1 into either the UBX1325 or sham study arms, in order to assess the primary objective. All patients will be followed for approximately 24 weeks.

Olympia / OPP-102

ClinicalTrials.gov Identifier: NCT04957758

A Phase 2, Multicenter, Randomized, Controlled, Double Masked, Clinical Trial to Evaluate the Efficacy and Safety of OC-01 (varenicline) Nasal Spray in Subjects with Neurotrophic Keratopathy (the Olympia Study)

This Study is currently closed for enrollment with patients remaining in followup care.

Detailed Description
Protocol OPP-102 is a Phase 2, a multicenter, randomized, controlled, double-masked study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with NK. Approximately 100 subjects at least 18 years of age with a physicians’ diagnosis of Stage 1 NK as defined by the Mackie Criteria and meeting all other study eligibility criteria will be randomized 1:1 and will receive OC-01 (varenicline)/ nasal spray or placebo nasal spray for 8 weeks three times daily (TID) as follows:

Unity / UBX1325-03

Clinicaltrials.gov ID: NCT05275205

A Phase 2a, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients with Neovascular Age-Related Macular Degeneration (wet AMD)

This Study is currently closed for enrollment with patients remaining in followup care.

Detailed Description
This is a Phase 2a Proof-of-Concept study, approximately 46 patients will be enrolled and randomized 1:1 into either UBX1325 or sham study arm. Patients will be followed for approximately 48 weeks.