For more than 30 years, Dr. Charles Campbell has been providing retinal care for patients throughout South Texas. Treatment options were limited for patients with diseases of the retina for many years; however, Campbell feels this is an exciting time to be in this area of ophthalmology. New drugs that are proven to improve vision in many diseases of the retina have been introduced, and additional drugs are currently being studied for their potential benefits.
The South Texas Retina Consultants’ Clinical Research Department was created in early 2006 to further the advancement of retina research. Campbell believes in utilizing cutting-edge treatment and surgical technology to preserve the vision of individuals with potential visual loss due to retinal disease.
Campbell feels that to further the advancement of retina research, it is important that the unique pathologies common in South Texas are represented in the studies. An additional benefit to the research volunteers is that the studies bring the cutting-edge treatments and surgical techniques to individuals without regard for their ability to pay.
Campbell has led multiple retinal trials. On June 22, 2010, the Food and Drug Administration (FDA) approved LUCENTIS (ranibizumab injection) for the treatment of macular edema (swelling) following retinal vein occlusion (blockage of a retinal vein). This approval was based on data submitted from two phase-three pivotal trials. Campbell and his research team were involved in both these trials. Results seen in our clinical setting were astounding, as study volunteers showed marked improvement.
The two trials named BRAVO and CRUISE evaluated the safety and efficacy of intravitreal LUCENTIS injections compared to sham (placebo) injections in macular edema following the occurrence of a retinal vein occlusion. Compared to those who did not receive study treatment, research participants who received LUCENTIS showed a statistically significant improvement in visual acuity at six months, which marked the primary endpoint of the study.
Is participation in a clinical trial for everyone? There are many things to consider…
Clinical research trials are studies that test how well new medicines work in people. Each study is set up to answer specific scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. People who take part in retina clinical trials have an opportunity to contribute to knowledge of all facets of retina disease. Our physicians have the most advanced medications and techniques available to treat participants through clinical studies; however, not all research volunteers may show improvement in their condition.
Clinical research sites are in frequent communication with the sponsoring drug company and independent review boards to ensure the safety of research participants and the integrity of the research trial. Every clinical trial has a protocol, or plan, for conducting the study that is determined by the drug company sponsoring the trial. The plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary.
Each study has its own rules about who can participate. Studies need volunteers with a certain type of disease process, including diabetic retinopathy, age-related macular degeneration and retinal vein occlusive disorders of the retina, to name a few.
People who volunteer to participate in a clinical trial will have the opportunity to have the potential risks, benefits, alternatives and responsibilities of the clinical trial explained to them before they agree to participate. When potential participants feel they understand what is involved with the clinical trial, they indicate their willingness to participate by communicating their agreement and signing a document. This process is called giving informed consent.
Ongoing participation in a clinical trial is always voluntary, and the patient is encouraged to discuss any concerns with the study staff and may elect to discontinue from the study at any time.
A volunteer for a clinical trial may receive some form of compensation for time and expenses, but not all clinical trials offer compensation. All research-related expenses, however, are covered by the drug company sponsoring the study.
People usually become aware of the opportunity to participate in a clinical study through one of their providers, word-of-mouth or publications and websites, such as clinicaltrials.gov. The website, clinicaltrials.gov, is the largest clinical trials database, currently holding registrations from more than 90,000 trials for various diseases and indications in the United States and the world.
Campbell is currently involved in several pivotal retinal trials; however, they are not open for enrollment. Please check our website at www.strc.cc occasionally, as new studies may open for enrollment in the near future.
