Clinical Trials Underway

HARBOR (Genentech)

Anti-VEGF (vascular endothelial growth factor) therapy by periodic intraocular injection has become commonplace for wet macular degeneration. Early studies suggest that less frequent injections at a higher dose than currently given in common practice may benefit patients and reduce exposure to potential adverse effects of the drug and repeated injections This active treatment controlled study assesses the efficacy and safety of 0.5mg (standard dose) versus 2.0mg (high dose) of monthly or as needed ranibizumab (Lucentis) in patients with wet age-related macular degeneration. The study is two years in duration with monthly visits.

COPERNICUS (Regeneron)

Anti-VEGF (vascular endothelial growth factor) medications such as Lucentis and Avastin are in common use for the treatment of macular edema related venous occlusive disease. VEGF Trap is a novel anti-VEGF agent that functions as a soluble decoy receptor that binds to VEGF, thereby preventing VEGF from binding to cell receptors. The Copernicus trial tests the safety and efficacy of VEGF Trap for macular edema secondary to CRVO. Subjects receive either 2mg of VEGF Trap or sham treatment every 4 weeks for the first 24 weeks. Then for weeks 24-52 subjects receive active drug or sham as needed according to treatment criteria. At the end of the first year, all subjects are eligible for a 1-year extension trial using VEGF Trap as needed. Pan retinal photocoagulation is applied as needed throughout the study.

CATT (National Eye Institute)*

The Comparisons of Age-Related Macular Degeneration Treatment Trials (CATT) is a multi-centered randomized treatment trial designed to assess the relative safety and efficacy of Avastin vs. Lucentis for subfoveal neovascular AMD. We have been selected as one of less than 50 sites across the U.S. to participate in the study. Patients are randomized to one of four treatment regimens: monthly Avastin, monthly Lucentis, Avastin on an “as needed” basis, or Lucentis on an “as needed” schedule. The study protocol is two years long.
*study is ongoing and active but enrollment is currently closed to new patients

VIEW (Regeneron)*

Afilbercept, also known as VEGF-trap, is being developed as an alternative intravitreal agent to Avastin and Lucentis for the treatment of neovascular AMD. VEGF-trap functions as a soluble decoy receptor and binds to VEGF (vascular endothelial growth factor), thereby preventing VEGF from binding to cell receptors. VEGF-trap may have a favorable duration of action when compared to current therapies. This two year comparison trial will assess the efficacy of various VEGF-trap dosing regimens when compared with monthly Lucentis.
*study is ongoing and active but enrollment is currently closed to new patients

RIDE (Genentech)*

Off-label intravitreal anti-VEGF agent treatment of diabetic macular edema is becoming commonplace. This multi-center randomized trial assesses the safety and efficacy of Lucentis for the treatment of diabetic macular edema.
*study is ongoing and active but enrollment is currently closed to new patients

REGRESS (Ophthotech)

Anti-VEGF medications such as Avastin and Lucentis are now standard treatment for many patients with wet macular degeneration. In the ongoing search for improved outcomes and efficacy, this 6-month study assesses the safety and efficacy of a novel supplemental medication, anti-PDGF (platelet derived growth factor) as a supplement to Lucentis injections. This new medication may enhance the effectiveness of standard Lucentis therapy, resulting in more visual gain for more patients. Patients in this study are randomized to receive standard Lucentis therapy alone or Lucentis with anti-PDGF. Enrollment is open only to patients who have not received prior treatment for wet macular degeneration.

LUXBIO

This study assesses the safety and efficacy of voclosporin as a therapy for noninfectionous uveitis involving the intermediate and/or posterior segments. Study participants are randomized to an oral calcineurin inhibitor (voclosporin) twice a day or placebo. The study measures the effect of treatment on treating and controlling the uveitis for 3 months.

GLAXO SMITH KLINE

Regular intravitreal injection of anti-VEGF agents is the current standard of care for patients with wet macular degeneration. Pazopanib is a tyrosine Kinase inhibitor that inhibits the VEGF signaling cascade at the receptor level and taking pazopanib orally may prove to be a more effective therapy for wet macular degeneration than repeated intravitreal injections of anti-VEGF drugs. This Phase I study evaluates the safety, tolerability, pharmacokinetics, exploratory efficacy and pharmacodynamics of oral pazopanib administered for 28 days in patients with treatment naïve wet macular degeneration.

THROMBOGENICS ADHESION TRIAL

Ocriplasmin is a recombinant human protein, a truncated form of the plasmin protein that has protease activity. Patients with macular degeneration and vitreous traction on the macula may benefit from release of the traction. This is a Phase II trial in which patients receive either a single injection of ocriplasmin or a sham injection, with follow-up visits and continuing care for macular degeneration for 12 months.

NOVARTIS, UVEITIS

Uveitis is commonly treated with steroid medications, but increasing efforts have been directed at developing non-steroid therapies. This is a Phase II trial studying the effects of AIN457, a monoclonal antibody that binds to the IL-17 receptors which are thought to play an important role in uveitis. This trial is for non-infectious uveitis patients, including intermediate, posterior or pan-uveitis. In this trial patients will either receive active drug or sham by intravenous infusion or a combination of intravenous infusion and subcutaneous injections.

Coming Soon

RACE (Alcon)

Some patients with wet macular degeneration do not respond as robustly as others to standard anti-VEGF (vascular endothelial growth factor) injections in the eye. This study tests a novel supplemental injection for patients who have already received between 3 and 12 injections in the past year, but still have evidence of persistent retinal thickening from macular degeneration. Patients are randomized to continued standard treatment with Lucentis or Lucentis with supplemental injections of a novel pharmaceutical agent with potential to achieve further regression of the disease. The trial lasts four months.

SHORE, GENENTECH

Intravitreal ranibizumab is a proven effective treatment for macular edema related to retinal vein occlusions. This Phase IV trial is designed to evaluate the efficacy of monthly versus “as needed” dosing of ranibizumab beyond 6 months of treatment. All subjects are on fixed monthly dosing through month 6. Starting at month 7, subjects are re-randomized into fixed or “as needed” treatment groups for follow-up through month 15. Enrollment includes both branch and central vein occlusion patients.

PACT, QLT

Despite many successes with intravitreal anti-VEGF injection therapy, some patients fail to respond completely to this treatment. This study is aimed at identifying these patients and studying their genetics and clinical characteristics in order to better classify them and target additional therapies that may be more effective.

REGENERON DME – PHASE III (Regeneron)

Avastin and Lucentis are both commonly used in an off-label fashion to treat diabetic macular edema (DME). VEGF Trap-Eye is a new drug with promise that has passed through early safety and efficacy studies and is now being evaluated for its utility in the treatment of diabetic macular edema as well. Patients enrolled in the study will be randomized to treatment with VEGF Trap-Eye treatment at 4 week or 8 week intervals after a loading phase or laser therapy. The trial is three years long.