Current Clinical Trials

Diabetic Macular Edema Background:

The macula is the small central part of the retina, which is responsible for straight-ahead vision. Over time, diabetes may affect the blood vessels within the eyes and the blood vessels that supply the eyes. These weakened blood vessels begin to leak and cause swelling in the macula. As swelling increases, central vision decreases, making it harder to read, perform computer work, etc. There are two Food and Drug Administration (FDA) approved treatments for diabetic macular edema (DME): focal laser treatment and Lucentis® injections. Currently, clinical trials are being conducted to determine if other drugs are as effective as Lucentis® or potentially better treatment options

 

Clinical Trials:

A Comparative Effectiveness Study of Intravitreal Aflibercept (Eylea®), Bevacizumab (Avastin®) and Ranibizumab (Lucentis®) for Diabetic Macular Edema

In follow-up. The purpose of this study is to determine if Avastin® and Eylea® work as well as Lucentis® for the treatment of DME.

 Proliferative Diabetic Retinopathy Background:

Patients with diabetes may develop two conditions in their eyes which can lead to severe vision loss. Proliferative diabetic retinopathy (PDR) is a condition in which new blood vessels and scar tissue form on the retina. The new blood vessels can cause bleeding in the eye. The other cause of vision loss is called diabetic macular edema (DME). Diabetic macular edema occurs when the leaky vessels cause swelling to develop in the central part of the retina called the macula. The macula is used when we are reading, working on a computer or any tasks which requires sharp vision. Currently anti-VEGF agents are being used to treat both PDR and DME.

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Active proliferative diabetic retinopathy (PDR) previously treated with panretinal photocoagulation (PRP). There is vitreous hemorrhage and fibrovascular membranes affecting the vision.

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Same eye after pars plana vitrectomy and epiretinal membrane removal. Vision has been restored.

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These photos of right and left eye demonstrate active PDR before PRP and show preretinal hemorrhage. Both eyes have had successful focal laser photocoagulation for macular edema. The fluorescein angiograms show active retinal neovascularization elsewhere (NVE) as the bright leaking areas next to retinal nonperfusion. PRP and anti-VEGF injections lead to regression of these vessels.

Clinical Trials:

Prompt Panretinal Photocoagulation versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy (DRCR Protocol S).

In follow-up. As stated above, the current approved treatment for PDR is a heavy laser treatment to the retina. The laser treatment can cause side effects, such as decreased night vision and reduced peripheral vision. Vascular endothelial growth factor (VEGF) is a substance which is responsible for the growth of the new blood vessels in the eye. An anti-VEGF drug is designed to reduce the amount of VEGF present in the eye, thereby decreasing the risk of the eye developing the new blood vessels which may bleed or cause a detachment of the retina. This trial is comparing the use of an anti-VEGF drug, ranibizumab to laser for the treatment of PDR. The purpose is to determine if ranibizumab will be as effective against the growth of the new vessels with fewer side effects to patients.

 

Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk (DRCR Protocol W)

This trial focuses on patients who are at a high risk of losing vison due to diabetic retinopathy. These patients have severe non-proliferative diabetic retinopathy, good visual acuity and no macular edema. Information from this study will help determine if it is cost effective and beneficial for patients to start preventive periodic injections of an anti-VEGF agent in the eye or observe until new vessels and/or edema develop and then treat.

 

Age-Related Macular Degeneration Background:

Geographic Atrophy associated with Age-Related Macular Degeneration

Geographic atrophy (GA) is the breaking down of the deepest cells in the retina which can cause scarring and vision loss. There are no treatments available for patients who develop GA.

 

Neovascular (Wet) Macular Degeneration

In neovascular macular degeneration, new blood vessels grow under the retina. The new blood vessels can be weak and may cause leakage or bleeding in the retina which leads to vision loss. We treat these new vessels by injecting an anti-VEGF medication into the eye. In our clinic, we use three drugs which are effective at treating these leaky vessels; Avastin, Lucentis and Eylea. These drugs are often used as frequently as every 4 weeks.

 

Non-exudative (Dry) Macular Degeneration with Geographic Atrophy

In dry macular degeneration there is drusen, pigment and retinal pigment epithelial (RPE) atrophy which can lead to slowly progressive vision loss. These abnormalities may be a precursor to wet macular degeneration.

 

Clinical Trials:

Multicenter, Randomized, Single-Masked, Sham Injection-controlled Exposure-Response Study of LampalizumabIntravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients with Geographic Atrophy

This clinical trial is designed to determine if injections of a drug called lampalizumab will help slow down the progression of the atrophy (scarring) in eyes with this form of dry macular degeneration.

 

A Phase III Study of the Efficacy and Safety of Squalamine lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration

This trial is being conducted to determine whether an eye drop, Squalamine Lactate, used in combination with Lucentis improves a patient’s vision better than Lucentis injections alone.

Completed Clinical Trials

Early termination by sponsor. This trial compared several dosages of sirolimus to placebo as a treatment for DME. Other clinical trials have shown sirolimus impedes many factors, which are responsible for new blood vessel growth

Completed. Laser in combination with ranibizumab, triamcinolone acetonide or sham for the treatment of DME. Ranibizumab is an anti- VEGF (vascular endothelial growth factor) drug. VEGF may play a role in the development of new blood vessels that form due to damage from diabetes. Triamcinolone acetonide is a steroid, which has been used off-label for the treatment of DME for several years. Sham treatments are not real injections into the vitreous; a needle-less syringe is placed on the eye to imitate an injection. The purpose of the trial was to determine whether the combination of drugs plus laser will be more effective than focal laser.

Completed. This trial used an intravitreal steroid insert, which slowly released the drug over time. Several doses were compared as well as time to re-treatment between injections. The insert Iluvien is now FDA approved for DME.

Completed. PDR (proliferative diabetic retinopathy) is an advanced disease state in which new abnormal blood vessels begin to grow along the retina. The new blood vessels are weak and increase a patient’s risk of developing bleeding in the eye (vitreous hemorrhage). The usual treatment for patients who have developed PDR is pan retinal photocoagulation. This is a laser, which is applied to the periphery of the retina in an effort to reduce the risk of bleeding. This trial compared the use of PRP and focal laser in combination with a steroid or ranibizumab to the use of only PRP and focal laser.

Completed. Subjects were treated with Lucentis or VEGF Trap. Lucentis and VEGF trap are drugs, which are classified as anti-VEGF (vascular endothelial growth factor) agents. VEGFs are responsible for the growth of blood vessels, which may leak and cause damage. The FDA has approved Macugen, PDT (photodynamic therapy) with Visudyne and Lucentis for the treatment of wet AMD. Based on this study the FDA has approved the drug Eylea.

Completed. Long term safety and tolerability extension study for VEGF Trap-Eye for the treatment of wet AMD.

 

Completed. The AREDS trial led to the development of nutritional supplements, which help to reduce the risk of certain individual’s progression from dry AMD to wet AMD. The focus of this trial was the possible improvement of the original formulation by adding lutein (a substance found naturally in the macula) and omega 3 fatty acids.

Early termination by sponsor. A combination of sirolimus/ placebo with lucentis used for the treatment of subjects with AMD. Other clinical trials have shown sirolimus impedes many factors, which are responsible for new blood vessel growth.

Safety and Efficacy Assessment Treatment Trials for Acucela Emixustat Hydrochloride

In follow-up. This trial is comparing three doses of Emixustat to a placebo as a treatment option for GA. In earlier studies of Emixustat, it was shown to be effective at slowing or stopping the progression of GA in study subjects.