View clinical trials related to Macular Edema.
Filter by:This is a prospective, observational study designed to evaluate the long-term safety and tolerability of ADVM-022 in participants with diabetic macular edema (DME). Participants who previously participated in the INFINITY parent study and received a single unilateral intravitreal dose of ADVM-022 are eligible for enrollment upon completion of the end of study visit in the parent study.
In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg).
This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is designed to assess the ability of the intended users, healthcare providers (HCPs), to follow the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events occurring during the 7-day study reporting period will be summarized.
This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not
This is a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
Researchers are looking for a better way to treat people who have diabetic macular edema (DME). Diabetic macular edema (DME) is a complication of diabetes. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Damaged blood vessels in the eye may lead to leakage of the fluid into the central part of the retina at the back of the eye (also called macula) where sharp, straight-ahead vision occurs. Fluid accumulation makes the macula swell and results in reduced vision. If not treated, DME can result in complete loss of central detailed vision. The study treatment intravitreal aflibercept (also called BAY865321) works by blocking VEGFR-1 receptor activity. Intravitreal aflibercept is already approved in over 105 countries for doctors to prescribe to people with DME. In India, aflibercept is approved conditionally for people with DME. The reason for this is that the sponsor was asked to collect more safety data for intravitreal aflibercept in Indian people with DME. The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome. The study participants will receive aflibercept as an injection directly into the space in the back of the eye once every 4 weeks in the first 5 months, followed by one injection every 8 weeks for the rest of the study duration. Only one eye per participant to be treated with aflibercept will be considered for the study. Each participant will be in the study for approximately 52 weeks. The treatment duration will be 48 weeks. For each participant 11 visits to the study site are planned. The study team will perform additional safety calls 16 to 36 hours after each visit starting at visit 2. Alternatively, an additional safety visit can be arranged/planned for the day after treatment. During the study, the study team will: - take blood and urine samples - examine the participants' eyes - do physical examinations - examine heart health using ECG - check vital signs - ask the participants questions about how they are feeling and what adverse events they are having. - in- administer the study drug At the end of the study the participants will be switched to commercially available treatment if recommended by the study doctor/if the participant still benefits from the treatment.
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.
During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.