Southwest Retinal Research Center Durango, CO
Contributing to the Advancement of Medical Treatments
Established in 2018, Southwest Retina Research Center serves the Four Corners area as the region’s only ophthalmic research site. We participate in clinical trials for new investigational treatments, including gene therapies and implantable devices for disease such as Macular Degeneration (wet and dry), Diabetic Retinopathy, and Glaucoma.
Clinical trials are critical for advancing medical treatment options and ensuring the safety of new drugs and devices. Some studies, called observational studies, collect long-term data on the progression of a disease to learn more about the disease itself, but do not test any new treatments.
The goal of ophthalmic clinical research is to find new, better ways for patients to retain their vision, and help researchers better understand how to diagnose, treat and prevent these diseases.
Safety Every Step of the Way.
An Institutional Review Board (IRB) oversees all research conducted by Southwest Retina Research Center to protect the rights, privacy, and welfare of all participants. Our staff maintains current regulatory training certifications to ensure compliance with the U.S. FDA, ICH E6(R3) Good Clinical Practice principles, and ISO 14155:2020 standards. These measures help ensure that every study we conduct follows the ethical principles outlined in the Belmont Report – respecting each individual, minimizing risk, and seeking benefits for both our volunteer participants and the future of medicine.
What are the Phases of Clinical Trials?
Just like the name implies, these studies watch patients as their disease progresses over time, but do not test any new treatments. Some Observational studies may use genetic testing to help researchers understand if there is a genetic component to the disease under study.
In Phase I studies, a new treatment is tested after having undergone extensive laboratory and animal testing, and in some cases, limited earlier human research. At this phase, a small group of participants are very closely monitored for any side effects, and information is gathered on how the drug/device interacts in the body. While early indicators of effectiveness may be observed, the main purpose of this phase is to establish whether the treatment is safe for people.
If the Phase I trial is successful the treatment moves to Phase II, where it is testing in a larger group of participants. Phase II studies continue to gather information about the safety and side effects of a treatment, while beginning to assess how well the treatment works. Researchers gather additional data to refine dosing, and further understand the treatment’s potential effectiveness.
Even more participants are enrolled in Phase III studies as more is known about the safety of the treatment. This larger group of participants in this phase helps researchers detect any side effects that may have gone unnoticed or not appeared in previous phases. At this phase, researchers aim to determine whether the treatment is beneficial in treating a disease. The experimental treatment is compared to currently available treatment options to determine if it is more effective and offers greater benefit. After successful completion of this phase, the treatment may be reviewed by the FDA for approval.
Once a drug or device has been approved by the FDA, Phase IV studies continue to monitor it’s safety and efficacy for broader use. This Post-Market Safety Monitoring provides additional information about long-term effects, optimal use, and potential rare side effects.
Interested in learning more?
At Southwest Retina Research Center, we conduct Phases I-IV clinical trials as well as observational studies. Over the years, the Research Center has participated in over 20 different clinical trials for various drugs and devices in different treatment areas. We have seen several treatments from studies we participated in gain FDA approval and become commercially available. Participation in clinical research contributes to advancing knowledge of treating diseases and offers research patients experimental treatment options.
If you are interested in learning more or becoming a research patient, please contact the Research Center at (970) 828-4164 or researchreferrals@sweyeconsultants.com, or speak with your Southwest Eye doctor at your next appointment.
Meeting Minutes
The National Institute of Health implemented a requirement for all relevant International Biosafety Committee minutes to be linked to on our website. Please find these notes for our site here.
