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    Enrolling Wet Macular Degeneration Clinical Trials

    • ARTEMIS Clinical Trial

      A multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 clinical research study to evaluate the efficacy and safety of Ixoberogene soroparvovec (Ixo-vec) in participants with Neovascular (Wet) Age-Related Macular Degeneration. ARTEMIS is investigating if a single injection of Ixo-vec can control Wet Macular Degeneration as effectively as the standard of care drug, EYLEA. If so, Ixo-vec may reduce the need for frequent anti-VEGF intravitreal injections.

      Potential participants must have active wet AMD and demonstrate a meaningful therapeutic response to anti-VEGF therapy to be eligible for evaluation for potential inclusion in the clinical trial.

      What is Ixo-vec?

      Ixoberogene soroparvovec (Ixo-vec; ADVM-022; AAV.7m8-aflibercept) is an investigational gene therapy product being developed for wet AMD. Ixo-vec uses a modified virus, known as an adeno-associated virus (AAV), which has been engineered so that it cannot replicate or cause infection. AAV is not known to cause disease in humans and has been previously used in gene therapy to effectively deliver genes into specific cells.

      In this case, Ixo-vec delivers a therapeutic gene to cells in the back of the eye. This gene enables the cells to produce aflibercept, a protein that reduces the growth of abnormal blood vessels and helps maintain vision. Aflibercept is the active ingredient in the approved anti-VEGF therapy, which is typically injected into the eye every 4 to 8 weeks to manage wet AMD. By enabling the eye to produce its own aflibercept, Ixo-vec may reduce the need for ongoing aflibercept injections.

      How is Ixo-vec Delivered?

      Ixo-vec is delivered through a procedure called intravitreal injection. This involves injecting the treatment directly into the vitreous, the gel-like substance inside the eye. The intravitreal injection allows the therapeutic genes carried by the AAV to reach the cells in the retina, where they can produce the aflibercept protein. The procedure is performed by an eye care professional using a fine needle and is typically done under local anesthesia to minimize discomfort.

      Who can participate in Adverum’s Phase 3 trial of Ixo-vec in wet AMD?

      You may be eligible to participate if you:

      • Are at least 50 years of age
      • Have been diagnosed with wet AMD and have active disease (i.e., presence of fluid on a non-invasive eye imaging test)
      • Have a visual acuity score between 35 and 78 ETDRS letters (20/200 to 20/32) in the study eye
      • Demonstrate a meaningful response to anti-VEGF therapy during the study screening period
      • Are able to reliably use eye drops as required by the study protocol

      You might not be eligible to participate if you:

      • Have any medical condition that contraindicates the use of Ixo-vec or compromises the participant’s ability to comply with planned study activities
      • Received any prior gene therapy
      • Experienced any active eye infections recently
      • Suffered a heart attack or stroke in the past six months
      • Have uncontrolled high blood pressure
      • Evidence of poorly controlled diabetes
      • Diagnosed with other serious eye conditions
      • Underwent major eye surgery in the last three months

      Why participate in this study?

      There is no guarantee that you will benefit from taking part in this study or that you will receive the study product. If you are randomized (a way of putting people into different groups at random) into the study product arm of the study, it is possible:

      • The study drug may decrease the need for regular aflibercept injections
      • There may be an improvement in your visual acuity or a slowing of progression of your visual loss from wet AMD
      • That the results may not help you individually but the information we get from the study will help us improve treatment for participants with the same disease as yours in the future
      • What are the potential risks of participating in this trial?
      • As with all research studies, the study product and study procedures may involve unknown risks. Any medication can have temporary and permanent side effects and can cause unforeseen adverse reactions, though not everyone gets them. The potential risks of participating in this clinical trial will be explained to you before you decide to participate.

      Costs and Benefits

      Travel support is available to get you to and from our Colorado Retina Associates Lakewood office for each of your study visits. There is also a monetary stipend offered to participants who meet a pre-defined level of compliance with procedures and study visits.

      References

      1. The information above is provided by Adverum Biotechnologies, Inc.
      2. Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants with Neovascular Age-Related Macular Degeneration (ARTEMIS). ClinicalTrials.gov identifier: NCT06856577. Updated April 27, 2025. Accessed April 28, 2025.

      Trial Overview

      • Sponsor: Adverum Biotechnologies, Inc.
      • Phase: 3
      • Drug: Ixoberogene soproparvovec (Ixo-vec) – Gene therapy
      • Condition: Wet Age-Related Macular Degeneration (wAMD)
      • Design: Randomized, double-masked, active-comparator-controlled
      • Duration: ~1 year dosing window, 5-year follow-up
      • Delivery: Single intravitreal injection of gene therapy
      • ClinicalTrials.gov ID: NCT06856577
      • Location: Colorado Retina Associates, Lakewood,CO

    Enrolling Geographic Atrophy Clinical Trials

    • JADE Clinical Trial

      Sponsor: Boehringer Ingelheim

      A Phase II Study for Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD)

      About the Study

      The JADE study is a Phase II clinical trial evaluating the safety and effectiveness of an investigational oral medication (BI 1584862) compared to placebo in patients with geographic atrophy (GA), a progressive and sight-threatening form of dry age-related macular degeneration (AMD).

      This trial explores whether this novel, first-in-class oral drug can slow or halt the progression of GA, potentially offering a less invasive alternative to intravitreal injections.

      Study Design

      • Double-masked, randomized study (neither patients nor study staff will know the treatment group)
      • Participants are randomly assigned to one of four treatment groups, which include different doses of BI 1584862 and placebo
      • Oral medication is taken over a period of 50 weeks
      • Study visits about every 4 weeks include retinal imaging (OCT and FAF) and health monitoring

      Eligible participants:

      • Age: 55 years or older
      • The total size of all GA lesions in the SE (as determined by the independent CRC) must be ≥1.25mm^2 and ≤12.0mm^2
      • If multiple lesions are present in the SE, at least 1 lesion must have an area of ≥1.25mm^2
      • At least 1 GA lesion must be at least in part within a 1500um radius ring centered of the fovea
      • The foveal center point must not be involved in any atrophic lesion
      • Lesion(s) must reside completely within the FAF 30 or 35 degree image
      • BCVA score ≥ 50 letters in the SE using ETRDS chart (approx. equivalent to ≥20/100 on Snellen chart)

      Ineligible participants:

      • Any history of or evidence of eAMD in the SE
      • Patients who received IVT treatment for GA (pegacetacoplan or avacincaptad pegol) for ≥ 12 months and/or received >6 injections in the SE. Patients treated for < 12 months who have received <6 IVT injections in the SE may be included after a washout period of at least 4 months between the last injection and randomization.
      • Uncontrolled glaucoma
      • clinically significant DR or maculopathy
      • History of high myopia
      • Anterior segment and vitreous abnormalities that would preclude adequate observation with SD-OCT
      • Other ocular conditions at the discretion of the investigator that might interfere with the outcome of the trial
      • Active intraocular inflammation in the SE
      • Currently enrolled in another investigational device or drug trial
      • Previously received gene therapy or cell therapy in 1 or both eyes

      Why Refer or Participate?

      • This is one of the first studies testing a non-injection treatment option for GA
      • Oral dosing may offer greater convenience and the ability to treat both eyes systemically
      • Participants receive extensive retinal imaging and monitoring by subspecialized retina physicians
      • Travel support to and from your home to our office for appointments
      • $100 stipend provided for each completed study visit

      Referral Support

      Referring providers can contact our clinical research directly for eligibility screening or to discuss specific patient cases. We provide detailed documentation and shared follow-up for all enrolled patients.

      To refer a patient or learn more, call or text 303-261-1600.

      Reference: ClinicalTrials.gov

      Trial Overview

      • Sponsor: Boehringer Ingelheim
      • Condition: Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD)
      • Study Drug: BI 1584862 (oral medication)
      • Goal: To evaluate whether oral BI 1584862 can slow or stop GA progression
      • Study Duration: ~50 weeks (13 visits total)
      • Location: Colorado Retina Associates, Lakewood, CO
      • Trial ID:: NCT06769048

    Enrolling Diabetic Retinopathy Clinical Trials

    • CRIMSON Clinical Trial

      Sponsor: Boehringer Ingelheim

      Exploring a New Treatment Option for Diabetic Retinopathy!

      The CRIMSON study is a Phase 2b clinical research trial evaluating the safety and effectiveness of a new investigational treatment, BI 764524, in people with diabetic retinopathy, specifically those who have moderate to severe NPDR and areas of the retina that have lost blood supply (known as retinal non-perfusion).

      The End Goal

      BI 764524 is being tested to restore blood flow to areas of the retina that are damaged by diabetes. By revascularizing ischemic (oxygen-deprived) areas and reducing leakage, the treatment (BI 764524) may help preserve vision and potentially prevent progression to more advanced stages of diabetic eye disease, including vision-threatening complications like proliferative diabetic retinopathy (PDR) or diabetic macular edema (DME).

      The CRIMSON study is double-masked (neither participants nor physician) will know which treatment is being given, to ensure objective results. Participants will be monitored closely with advanced imaging and regular check-ups.

      Eligible Participants:

      • Age: ≥ 18 years
      • Diabetes: Type 1 or 2, on stable treatment ≥ 30 days
      • Visual Acuity: BCVA in study eye ≥ 20/100
      • NPDR Severity: DRSS 47–53 (moderately severe to severe NPDR), confirmed by reading center
      • Retinal Non-Perfusion (RNP): ≥ 12.5 mm² of ischemia on ultra-widefield FA (within 17.5 mm radius centered on fovea)
      • HbA1c: ≤ 12%

      Ineligible Participants:

      • Proliferative diabetic retinopathy in the study eye
      • Clinically significant macular edema (CSME): center-involving DME with CST ≥ 320 µm (men) or ≥ 305 µm (women)
      • Any prior intravitreal treatment for NPDR or DME in the study eye within 6 months using anti-VEGF agents (including anti-VEGF/Ang2 therapies)
      • Any previous intravitreal treatment in the study eye other than anti-VEGF, including steroids
      • Prior panretinal photocoagulation (PRP) involving ≥ 100 burns outside the posterior pole
      • No significant other ocular pathology: retinal vein occlusions, uveitis, endophthalmitis, epiretinal membrane, macular hole, etc.
      • Recent ocular surgery, including cataract surgery in the past 3 months

      Why Participate?

      • Access to a cutting-edge, novel treatment aimed at treating retinal non-perfusion, something no current therapy directly addresses
      • Careful eye health monitoring by retina specialists throughout the study
      • Opportunity to contribute to research that could change the future of diabetic eye care
      • Stipends for participation and travel support may be available
      • May help preserve vision longer and delay or prevent the need for more invasive treatments like ocular injections

      Learn More

      If you're living with diabetic retinopathy and want to explore advanced care options, the CRIMSON trial may be a promising opportunity.

      To refer a patient or learn more, please contact the Colorado Retina Associates research team at 303-261-1600.

      Reference: www. clinicaltrial.be

      Trial Overview

      • Condition: Moderate to severe non-proliferative diabetic retinopathy (NPDR) with retinal non-perfusion
      • Drug: BI 764524 (anti‑Sema3A monoclonal antibody)
      • Study Duration: 72 weeks (~1.5 years)
      • Goal: Improve retinal blood flow by re-vascularizing ischemic areas and reducing leakage
      • Location: Colorado Retina Associates, Lakewood, CO
      • External ID: NCT06321302