Currently Enrolling Clinical Trials
Before deciding to participate in a clinical trial, you should talk to your physician. Clinical trial participants enroll to possibly receive the newest treatment for their conditions, as well as to have additional care and attention from clinical trial staff and to help researchers find better treatments for future patients.
In the United States, clinical trials must meet rigorous standards and be registered with the National Institutes of Health. Registered trials are listed at clinicaltrials.gov as part of a searchable database.
Diabetic Macular Edema Trials
Alimera 01-20-005
This is a randomized, masked, active-controlled, parallel-group, multi-center study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of Center Involving DME (CI-DME). Patient participation is up to 18 months.
Participant requirements:
- Diagnosis of type 1 or type 2 diabetes.
- Either treatment naïve or have not received any DME treatments for the preceding 12 months as documented in medical records.
- Male or female patients >18 years of age at the time of consent.
- Best-Corrected Visual Acuity (BCVA) of <80 ETDRS Letters and ≥35 ETDRS letters in the study eye at Screening Visit.
- Female patients of childbearing potential must not be pregnant or breastfeeding.
Oxurion THR-687-002
A phase 2, randomized, muticentre study to assess the dose level of multiple THR-687 injections and to evaluate the efficacy and safety of THR-687 versus aflibercept for the treatment of diabetic macular edema (DME).
Participant requirements:
- Male or female aged 18 years or older.
- Type 1 or type 2 diabetes
- Treatment naïve study eye with known diagnoses of DME ≤ 12 months prior to screening procedures or previously treated study eye with known diagnoses of DME for ≤ 36 months prior to screening procedures.
Dry AMD Trials
Iveric ISEE2008
A phase 3 multicenter, randomized, double masked, sham-controlled clinical trial to assess the safety and efficacy of intravitreal administration of Zimura (complement c5 inhibitor) in patients with geographic atrophy secondary to age-related macular degeneration. The objective of this study is to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Participant requirements:
- Subjects of either gender aged ≥ 50 years
- Diagnosis of Non-foveal geographic atrophy (GA) secondary to dry AMD
Clover Therapeutics
This study is focused on understanding how genetics and lifestyle affect Age-related Macular Degeneration. This is not an interventional study; Clover Therapeutics will not draw blood and will not give medication. The researcher is just looking to observe this condition through a health survey and a saliva sample to better understand the disease.
Participant requirements:
- Age 50 or older
- Has at least 3 years of AMD history
- Intermediate or advanced dry AMD in at least one eye
Alexion ALXN2040-GA-201
This is 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.
Participant requirements:
- Age ≥ 70 years, male or female.
- Documentation of vaccination for Neisseria meningitidis: All patients must be vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug. Patients who initiate study drug treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
- For female patients, confirmation of non-childbearing potential based on follicle-stimulating hormone (FSH) test at Screening only.
- For nonsterile male patients, agreement to use a highly effective or acceptable method of contraception with their partner(s) of childbearing potential from the first day of dosing to 90 days after their last dose of study drug. Males who are surgically sterile do not need to employ additional contraception.
- For male patients, agreement not to donate sperm while enrolled in this study and for 90 days after their last dose of study drug.
Wet AMD Trials
Opthea OPT-302-1004
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 neovascular age-related macular degeneration (NAMD).
Participant requirements:
- Male or female participants at least 50 years of age.
- Active subfoveal CNV lesion or juxtafoveal CNV lesion.*
- An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
REGENXBIO RGX-314-2104
RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). This randomized, partially masked, controlled, phase 2b/3 clinical study will evaluate the efficacy and safety of RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 relative to an active comparator.
Participant requirements:
- Age ≥ 50 years and ≤ 89 years
- An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
- Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF
- Must be pseudophakic (at least 12 weeks post cataract surgery) in the study eye.
Uveitis Trials
Eyepoint Yutiq EYP-YUT-0001
A retrospective registry study to collect real-world data on Yutiq, a fluocinolone acetonide intravitreal implant, for the treatment of chronic non-infectious uveitis affecting the posterior segment. The purpose of the study is to collect data on a cohort of patients treated with fluocinolone acetonide intravitreal inserts for the analysis of efficacy outcomes and adverse events and to determine local or systemic factors which might predict treatment response and identify adverse safety events.
Participant requirements:
- Patients with chronic, non-infectious uveitis affecting the posterior segment of the eye
- Men and women ≥ 18 years old
Macular Telangiectasia Trials
Lowy Medical Research Institute NHOR
A natural history observation and registry study of macular telangiectasia type 2.
Participant requirements:
- Must have a confirmed clinical diagnosis of MacTel Type 2.
- Must be 18 years of age or older.
- Should not have diabetic retinopathy with 10 or more microaneurysms.
- Have no confounding ocular conditions that may now or in the future complicate the evaluation of MacTel Type 2.
Nonproliferative Diabetic Retinopathy Trials
Roche BP41321
A randomized, double-masked, 48-week, parallel-group, placebo-controlled, proof-of-concept study to investigate the efficacy and safety of rg7774 in patients with diabetes mellitus type 1 or type 2 with treatment-naïve diabetic retinopathy. The objective is to assess the effect of RG7774 on the severity of diabetic retinopathy and evaluate the safety and tolerability of RG7774.
Participant requirements:
- Diagnosis of DM type 1 or type 2
- Current regular use of insulin or other injectable drugs for the treatment of diabetes
- Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
- HbA1c 10%.
- Willingness to refrain from cannabinoid use for the entire duration of the study
Branch Retinal Vein Occlusion (Brvo) Trials
Roche GR41984 BRVO
A phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to branch retinal vein occlusion. This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to BRVO up to the primary endpoint at Week 24.
Participant requirements:
- Age ≥ 18 years at time of signing Informed Consent Form
- Foveal center–involved macular edema due to BRVO
- BCVA of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent), as assessed on the ETDRS visual acuity chart at a starting test distance of 4 meters
Central Retinal Vein Occlusion (Crvo) Trials
Roche GR41986
A phase III, multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of faricimab in patients with macular edema secondary to central retinal or hemiretinal vein occlusion. This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to CRVO or HRVO up to the primary endpoint at Week 24.
Participant requirements:
- Age ≥ 18 years at time of signing Informed Consent Form
- Foveal center–involved macular edema due to CRVO or HRVO, diagnosed no longer than 4 months prior to the screening visit and confirmed by CRC based on SD-OCT (or SS-OCT) images
- BCVA of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent), as assessed on the ETDRS visual acuity chart at a starting test distance of 4 meters on Day 1
Reach Out Today to See if You Might Be a Candidate!
Please fill out the form below, or contact Kari Winger, Research Manager at research@coloradoretina.com or 719-473-9595 x130 for more information regarding our clinical trials.