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Clinical Trials

Unity / UBX1325-03

Clinicaltrials.gov ID: NCT05275205

A Phase 2a, Prospective, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Safety, Tolerability and Evidence of Activity of a Single Intravitreal Injection of UBX1325 in Patients with neovascular Age-Related Macular Degeneration (nAMD)

Detailed Description
This is a Phase 2a Proof-of-Concept study, approximately 40 patients will be enrolled and randomized 1:1 into either UBX1325 or sham study arms. Patients will be followed for 16 weeks.
Inclusion Criteria
  • Patients aged ≥ 50 years.
  • Neovascular AMD patients who had at least 3 anti-VEGF treatments in the preceding 6 months prior to Day 1, with the last anti-VEGF given between 3 and 6 weeks prior to Day 1
  • BCVA in the study eye of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart).
  • BCVA in the non-study eye of 35 ETDRS letters (equivalent to 20/200 on the Snellen chart) or better.
Exclusion Criteria
  • Concurrent disease in the study eye or structural damage, other than nAMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye.
  • Subretinal hemorrhage with bleeding area ³4 disc area in the study eye    
  • Concomitant use of >2 medications for the treatment of glaucoma and unstable glaucoma in the study eye (i.e., inadequate IOP control)  
  • Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study 
  • Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging 
  • Intraocular surgery, including cataract surgery, in the study eye ≤3 months of screening 

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.

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.

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)

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:
Inclusion Criteria
  • Be at least 18 years of age at Visit 1.
  • Patients with Stage 1 (corneal epithelial hyperplasia/punctate keratopathy) NK in one or both eyes, as defined by the Mackie Criteria.
  • Evidence of decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) in at least 1 corneal quadrant.
  • Schirmer's test without anesthesia >3 mm/ 5 minutes in the affected eye with a cotton swab nasal stimulation Schirmer's Test score at least 7 mm greater in the same eye
  • Have provided verbal and written informed consent.
  • If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include hormonal - oral, implantable, injectable, or transdermal contraceptives, mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner), and have a negative urine pregnancy test on Day 1.
Exclusion Criteria
  • Have Stage 2 or Stage 3 NK affecting one or both eyes.
  • Have ocular graft versus host disease or Stevens-Johnson syndrome.
  • Have any active ocular infection (COVID-19 conjunctivitis, bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in the affected eye.
  • Be currently receiving autologous serum tears, amniotic membrane, Fresh Frozen plasma or cord blood derivative tears.
  • Have severe blepharitis and/or severe meibomian gland disease in the study eye.


Continuing education provided by the physicians of Eye Care Center of Northern Colorado.