Pinellas Park

Researchers are evaluating the effects of two different methods of giving pegloticase, a drug for uncontrolled gout, combined with methotrexate (MTX). This Phase 3 trial compares pegloticase given as an 18 mg injection under the skin every two weeks with pegloticase given as an 8 mg intravenous (IV) infusion every two weeks, both alongside weekly oral MTX. The main goal is to see which method better maintains normalized serum uric acid levels below 6 mg/dL for at least 80% of the time during the sixth month of treatment. Participants will be randomly assigned to receive pegloticase either by subcutaneous injection or intravenous infusion every two weeks, along with weekly oral doses of methotrexate. Both groups will be treated over several months while closely monitored. The study is double-blind, meaning neither participants nor researchers know which treatment is being given to maintain unbiased results. During the trial, participants will undergo regular assessments to monitor their serum uric acid levels and overall response to treatment, especially focusing on weeks 20 through 24 (Month 6). Safety and efficacy will be tracked throughout the study, including how well participants tolerate the treatments and any side effects. The study's main measure is the proportion of participants who achieve a sustained uric acid response during Month 6.

Researchers are evaluating multiple independent pain treatments under a master protocol designed for chronic pain conditions including osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. This phase 2 study aims to compare different interventions through disease-state addenda and intervention-specific appendices to better understand their effects on chronic pain. Participants may receive various investigational drugs administered either orally or intravenously, including LY3016859 (IV), LY3556050 (oral), LY3526318 (oral), LY3857210 (oral), or placebo versions given orally or intravenously. Each intervention-specific appendix may begin independently as treatments become available for clinical testing, following the master protocol structure. During the study, participants will be monitored for pain levels using specific scales and assessments related to their condition. Researchers will track the number of participants assigned to each intervention from baseline through week 8. Participants must maintain consistent non-drug pain therapies and discontinue chronic pain medications except for rescue medication during the study. Safety assessments, including physical exams and laboratory tests, will be conducted to ensure participant well-being throughout the trial.

Researchers are studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness and safety of SP-624 compared to a placebo in adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD). This Phase 2B study focuses on treating this condition and assesses changes in depression severity using the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 4. Participants receive either SP-624 or a placebo once daily. The SP-624 treatment consists of two capsules taken orally each day, providing a total dose of 20 mg. Those in the placebo group take two matching placebo capsules daily. The study is designed as a multi-center, double-blind, randomized, placebo-controlled trial. During the study, participants will be monitored for changes in depression severity through the MADRS assessment from the start of the study to week 4. Researchers will also evaluate safety and tolerability throughout the treatment period. The total study duration and specific follow-up details are not provided but include careful observation of participants' health and response to treatment.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Researchers are evaluating the effectiveness of EYP-1901 compared to Aflibercept in treating people with diabetic macular edema (DME), a condition related to diabetic retinopathy that affects vision. This is a phase 3, randomized, double-masked study designed to compare these two treatments. The study focuses on participants who have either been treated before or are new to treatment with documented macular edema due to diabetic retinopathy. Participants will receive either EYP-1901 or Aflibercept through intravitreal injections, which involve injecting the drug directly into the eye. The study is designed to be double-masked, meaning neither participants nor researchers know which treatment is being given, to fairly assess the effects of each drug. The treatments are given during the study period, with careful monitoring of vision changes. During the study, participants will have their best-corrected visual acuity (BCVA) measured using standardized eye charts at weeks 52 and 56 to observe changes in their vision. Researchers will monitor the participants closely to evaluate safety and effectiveness throughout the study. The total duration for participants includes screening, treatment, and follow-up assessments to ensure comprehensive evaluation of the treatments.

Researchers are evaluating the effect of fenofibrate compared with placebo in preventing worsening of diabetic retinopathy (DR) over six years in people with mild to moderately severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at the start. The study also aims to test a model where ophthalmologists collaborate with primary care providers like internists or endocrinologists to safely prescribe and monitor the drug. Additionally, the study will assess how blood sugar variability relates to DR outcomes and will include additional studies to understand functional and structural eye changes in participants. Participants will receive either fenofibrate or placebo daily with food, with the dose (either 160mg or 54mg) chosen based on kidney function measured at screening. The dose may be adjusted during follow-up according to the study protocol. The trial is randomized and includes a comparison between the fenofibrate and placebo groups. During the study, participants will be monitored for worsening of diabetic retinopathy over six years. Eye health will be assessed through specialized grading of fundus photographs and visual acuity tests. Kidney function and blood sugar variability will also be tracked. The main outcome measured is the progression of diabetic retinopathy. Researchers will observe safety and effectiveness while participants remain in the study for the full six-year period.

Researchers are evaluating two treatment strategies for neovascular age-related macular degeneration (nAMD), a condition that affects vision in people aged 50 and older. This Phase 3 trial compares a standard "Treat and Extend" (T&E) dosing schedule of anti-vascular endothelial growth factor therapy with a newer approach guided by home optical coherence tomography (OCT) imaging. The study aims to find out if daily home OCT monitoring can improve visual acuity outcomes and reduce the number of injections needed over a period of 104 weeks compared to the standard T&E approach. Participants receive intravitreal injections of 6 mg faricimab, either on a Treat and Extend schedule or guided by daily home OCT scans. At baseline, participants undergo vision tests, ocular exams, and imaging, followed by a faricimab injection. Those eligible for randomization are assigned to one of the two treatment groups. The T&E group returns for office visits every 4 to 18 weeks, while the home OCT group performs daily self-scans and only visits the clinic if fluid above a certain threshold is detected. The study follows participants for 104 weeks, with key visits at 52 and 104 weeks. Participants are involved in daily home OCT scanning if assigned to that group, attend scheduled visits for vision and imaging assessments, and undergo monitoring for treatment response and safety. Researchers measure changes in visual acuity using the E-ETDRS letter score and count the number of faricimab injections over the two-year period. The study also assesses adherence to daily scanning and evaluates treatment burden and outcomes for each approach to managing nAMD.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and lasting effects of AR-14034 Sustained Release (SR) implant in people with neovascular age-related macular degeneration (nAMD). This study has two stages, starting with a dose-escalation phase to assess safety and preliminary effects, followed by a randomized comparison with an approved treatment called aflibercept. The trial is designed as a Phase 1/2 study to better understand how well AR-14034 SR works and how long its benefits last compared to standard therapy. In Stage 1, about 10 participants will receive one of two dose levels of AR-14034 SR via an intravitreal implant and be followed for 48 weeks to monitor safety and early treatment response. In Stage 2, approximately 130 participants will be randomly assigned to one of three groups: one injection of AR-14034 SR, two injections of AR-14034 SR, or aflibercept injections as currently labeled. This stage lasts 56 weeks, followed by a 16-week open-label extension phase where participants continue to be observed. Participants will attend multiple visits throughout the study to assess visual acuity using standard eye charts and monitor safety. Researchers will collect data at baseline, Week 44, and Week 48 to measure changes in vision. Additional assessments include eye exams and evaluations for any side effects during and after treatment. The total duration for participants ranges from 48 to 72 weeks depending on the stage and extension phase involved.