This trial is evaluating whether Port Delivery System with Ranibizumab will improve 2 primary outcomes and 21 secondary outcomes in patients with Wet Macular Degeneration. Measurement will happen over the course of Baseline up to Week 24.
This trial requires 200 total participants across 2 different treatment groups
This trial involves 2 different treatments. Port Delivery System With Ranibizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
"Wet AMD was not cured clinically by the laser photocoagulation of the macular atrophic retina. Results from a recent paper were obtained in very selected and highly selected cohorts of patients that have a very low probability of developing wet AMD. In routine clinical practice, patients with wet AMD are usually not selected for laser photocoagulation. Results from a recent paper of laser photocoagulation of early stage wet AMD are therefore not predictable." - Anonymous Online Contributor
"Around 135,000 Americans are diagnosed each year with wet macular degeneration. Approximately 65,000 of these cases are bilateral, and it is the most common cause of blindness in adults over the age of 55. wet macular degeneration is also a common cause of vision loss and is one of the major causes of visual impairment in Americans. wet macular degeneration accounts for approximately 382,000 deaths across the United States each year. There seems to be an increasing incidence of wet macular degeneration, but the cause for the surge remains unclear. wet macular degeneration is also the third leading cause of blindness in the United States." - Anonymous Online Contributor
"The main sign of wet macular degeneration is typical vision loss in central and near vision. This is often accompanied by the visual field defect and peripheral vision loss may also be seen. A swollen optic disc," - Anonymous Online Contributor
"Photodynamic therapy (PDT) is an emerging treatment. Laser therapies are sometimes used as initial therapy for dry macular degeneration. The use of multiple or multiple-drugs therapy is common with wet macular degeneration. The use of anti-VEGFs may be beneficial. Laser treatment may be useful in very dry (age-related macular degeneration) or wet forms of macular degeneration, although the precise indications and effectiveness remain unknown. Photodynamic therapy is an emerging treatment for wet macular degeneration. Laser therapies are sometimes used as initial therapy for dry macular degeneration." - Anonymous Online Contributor
"Although there is no significant evidence of an environmental factor associated with wet AMD, this study does suggest that a genetic predisposition to developing wet AMD is associated with an increased number of high-affinity ocular receptors for vascular endothelial growth factor." - Anonymous Online Contributor
"Wet macular degeneration (wet AMD) is a group of age-related diseases in which the macula (imaging site of the center of the eye) is damaged." - Anonymous Online Contributor
"The port delivery system appears to have a potential role in improving the efficacy and safety profile of ranibizumab compared with a conventional, controlled--release formulation after 1 year of administration. Clinicaltrials." - Anonymous Online Contributor
"Ranibizumab with the Port injection system is effective and well tolerated in patients with neovascular AMD. Although not long term data are available, the results were similar to those with 1.5 mg ranibizumab administered via intravitreal injection. Port injection of ranibizumab may reduce drug-related injection-site disorders and improve compliance in this patient population." - Anonymous Online Contributor
"Treatment with a port system containing ranibizumab is associated with a significant improvement in the best quality of life among those who require additional injection, especially those who already had a suboptimal response or had had poor visual outcomes with ranibizumab injections." - Anonymous Online Contributor
"WMD has a high recovery rate in visual acuity and the majority of patients also reported a significant improvement in their quality of life. Further, the treatment is fairly well tolerated and a significant percentage of patients even reported improvement in overall health. It thus has the potential to revert the deterioration to pre-existent level, and offer a very viable treatment option to patients who wish to control their neovascularized retina. Overall these features make [wet macular degeneration](https://www.withpower.com/clinical-trials/wet-macular-degeneration) a less severe and more manageable condition compared to dry age-related macular degeneration, with the opportunity of improving the quality of life for the patient." - Anonymous Online Contributor
"The benefits of wet AMD therapy must be balanced against the potential harms. The burden of wet AMD remains high: about a third of patients and one third of all AMD patients have significant visual impairment." - Anonymous Online Contributor
"In 2006, one of the first therapeutic interventions for wet AMD was a new class of drugs developed for the treatment of metastatic cancer. These new treatments were the first drugs introduced to treat wet macular degeneration for which “off-label” use has been initiated. Although the success of these new drugs was found to be limited, they demonstrated that using drugs used successfully to treat metastatic cancer proved to be valuable for treating wet AMD. In addition, a number of advances in treatment were made in the last 10 years." - Anonymous Online Contributor