Diabetic Macular Edema (DME) Clinical Trials
DME is a chronic condition that can cause vision loss among people with diabetes. Diabetic macular edema can cause blurred or distorted vision, as well as causing colors to appear to be washed out. It is caused by damage to blood vessels in the retina (the light-sensitive layer in the back of the eye responsible for your vision). Hyperglycemia (high blood sugars) can cause the vessels to leak blood or fluid into the macula. The leakage of fluid into the retina is called ‘edema’ and may result in reduced vision. If left untreated, macular edema can lead to permanent, irreversible vision loss. A protein called vascular endothelial growth factor (VEGF) is involved in the development and leakiness of blood vessels in the retina. Your doctor may recommend treatments that block this protein in order to prevent the vessels from continuing to leak.
Pagoda – Genentech’s PAGODA trial is exploring a novel treatment for diabetic macular edema with their implant delivery system of VEGF inhibiting medication (Port Delivery System with Ranibizumab), which recently gained approval for use in the treatment of age-related macular degeneration. Patients are placed into either the group that will receive the implant at the front end of the trial, or the group that will receive monthly intravitreal ranibizumab injections throughout the trial. The ocular implant releases ranibizumab continuously into your eye, and the contents of the implant can be exchanged with fresh ranibizumab by your study doctor. Because of the continuous release of drug into the eye, patients treated with the implant may need fewer or possibly no further injections to maintain their vision and keep macular edema levels at a minimum. This study will help determine whether ranibizumab delivered continuously through an ocular implant is similar in effectiveness to ranibizumab injections into the eye for treating patients with DME.
Kalahari – Oxurion’s Kalahari trial is testing the durability and efficacy of THR-149 versus aflibercept. THR-149 is hypothesized to have a greater therapeutic benefit than aflibercept because it a has broader mechanism of action in blocking the proteins associated the diabetic macular edema. Part B of this trial is currently active and enrolling patients who have had suboptimal responses to the standard of care therapy Aflibercept.
Glimmer – Kodiak’s phase 3 GLIMMER study is a global, multicenter, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). Patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every 8 to 24 weeks after only three loading doses or intravitreal aflibercept every 8 weeks after five loading doses per its label.
Altimeter – The purpose of this study is to explore relationships over time between different kinds of assessments (vision, imaging, eye chemistry, and genetics) in subjects with DME who are treated with faricimab. Before this study, more than 2100 people received at least one dose of faricimab. In addition, more than 1600 people with either DME or another eye disease known as neovascular age-related macular degeneration (nAMD; often referred to as “wet AMD”) received at least one 6 mg dose of faricimab.
Longitude – This is an open-label study (meaning both you and your doctor will know what study treatment you are receiving). If you have DME, you will receive an intravitreal injection of Eylea® every 4 weeks (monthly) for the first 5 months, followed by an intravitreal injection after 8 weeks (2 months) into the study eye. You will receive six injections in total.
Wet Age-Related Macular Degeneration (nAMD) Clinical Trials
Burgundy BP41670 – Roche’s Burgundy study is looking at the novel therapy RO7250284, which targets angiopoietin-2 (Ang-2), in addition to VEGF. Ang-2 (like VEGF) is involved in the growth of abnormal blood vessels and it is hypothesized that simultaneous inhibition of VEGF and Ang-2 has better effects on the abnormal blood vessels causing nAMD than inhibiting VEGF alone. This is the first time RO7250284 is being used in humans. This study is divided into two parts. Part 1 will test the effects of RO7250284 when it is injected into the eye. Part 2 will test the effects of RO7250284 when it is delivered by a device about the size of a rice grain that is surgically inserted into the eye. This device releases RO7250284 into the eye over a long period and can be refilled when needed. The long-term release of RO7250284 may reduce the need of frequent injections into the eye. Both the injection and the device will be tested in the same eye (the study eye). If you decide to take part in this study, you have the choice to take part only in Part 1 or in both parts (Part 1 and Part 2).
Atmosphere- REGENXBIO’s Atmosphere trial is exploring efficacy of the novel one-time gene therapy RGX314 for the treatment of wet age-related macular degeneration. This phase III trial is enrolling 300 patients to be treated with either one-time gene therapy subretinal injection or monthly intravitreal injections for the treatment of wet AMD. Patients are enrolled for approximately two years.
Ascent- REGENXBIO’s Ascent trial is exploring efficacy of the novel one-time gene therapy RGX314 for the treatment of wet age-related macular degeneration. This trial is the sister study to the Atmosphere study above and uses the same experimental therapeutic and surgical delivery method. This phase III trial is enrolling 300 patients to be treated with either one-time gene therapy subretinal injection or bimonthly intravitreal injections for the treatment of wet AMD. Patients are enrolled for approximately one to two years.
LUNA – In Adverum’s phase two Luna trial, patients will receive one of two doses of ADVM-022 to evaluate its safety, tolerability, and efficacy in the treatment of wet AMD. The gene therapy agent is delivered by one-time injection into the back of the eye with various methods of prophylactic steroids, depending on the patients assignment in the study. Patients are followed for one year in the trial.
Dry Age-Related Macular Degeneration (AMD) Clinical Trials
HORIZON– Gyroscope’s Horizon trial is looking at the effectiveness of a one-time, subretinal injection of GT005, a recombinant adeno-associated viral vector containing gene expression material for human Complement Factor I (CFI). Patients will receive one of two doses of GT005, or enter into the placebo arm of the study. All patients will be tracked for two years to monitor the progression of geographic atrophy secondary to macular degeneration. Geographic atrophy and dry macular degeneration are currently untreatable diseases which often cause progressive and significant vision loss. While the GT005 will not reverse vision loss associated with the disease, it may slow or prevent the progression of vision loss.
LNP023 – Novartis’s CLNP023E12201 trial is looking to evaluate the safety and efficacy of Iptacopan in the treatment of early to intermediate age-related macular degeneration in one eye and wet age-related macular degeneration in the other. Patient must have one high risk feature associated with their early to intermediate age-related macular degeneration to be eligible for the trial. The oral medication is taken daily to evaluate its effect on the progression of age-related macular degeneration versus placebo.
Retinal Vein Occlusion (RVO) Clinical Trials
Beacon– The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the durability, efficacy and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. Following this, patients can continue to receive KSI-301 for an additional six months on an individualized basis.
Diabetic Macular Ischemia (DMI) Clinical Trials
Diabetic macular ischemia (DMI) is a troublesome complication of diabetes mellitus. It is a condition that occurs when there is lack of blood flow to the eye due to uncontrolled diabetes. The pathogenesis, progression, consequences, and treatment options for this disease are still poorly understood. However, it is believed that this complication is associated with several risk factors like poor glycemic control and high blood pressure.
Hornbill – Boehringer Ingelheim’s Hornbill trial is exploring the tolerability of a medicine called BI 764524. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.
Partridge – Boehringer Ingelheim’s Partridge trial is exploring the tolerability of a medicine called BI 765128. The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B. In part B, participants are put into 2 groups randomly. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. In this part, participants receive study treatment once every month for 3 months.
Diabetic Retinopathy (DR) Clinical Trials
NEON-NPDR – This phase 2 trials is investigating the efficacy of the oral therapy runcaciguat compared to placebo in the treatment of diabetic retinopathy. Patients are followed for one year, while taking a total of 8 tablets once daily.
DRCR- AF – The DRCR Retina Network has given us many insights into the evaluation and management of diabetic retinopathy (DR) by exploring the resulting outcomes of various approved therapies and treatment regimens. In Protocol AF, we are exploring the effect of Fenofibrate, an oral medication, on the prevention of worsening diabetic retinopathy.
Epiretinal Membrane (ERM) Clinical Trials
DRCR AM- The DRCR Retina Network is currently investigating immediate versus deferred surgery for the treatment of vision-affecting epiretinal membranes. Patients are randomly assigned to either have surgery immediately or the have surgery deffered until further vision decline from the ERM is observed.