Retina Associates Research Institute & Clinical Trial Network

Current Clinical Trials as of January 2019

Active & Enrolling Studies

Neovascular Age-Related Macular Degeneration

Protocol Title: Safety and Efficacy of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

Purpose: This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration. Patients will reiceive either abicipar pegol or ranibizumab (Lucentis)

Medications: Provided by the study. Abicipar Pegol, Ranibizumab.

Ages Eligible for Study: 50 Years and older

Protocol Title: Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD (MAKO)

Purpose: A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is 2 years.

Medications: Provided by the study. Squalamine Lactate Ophthalmic Solution, Ranibizumab.

Ages Eligible for Study: 50 Years and older

Upcoming Studies

Graybug Vision

Neovascular Age-Related Macular Degeneration

Protocol Title: A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects with Neovascular Age-related Macular Degeneration.

Purpose: To evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.

Medications: Provided by the study. Aflibercept and GB-102

Ages Eligible for Study: 50 Years and older

Protocol Title: A Phase 2 Study of RO6867461 in Participants With Center-Involving Diabetic Macular Edema (CI-DME) (BOULEVARD)

Purpose: This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 28-week study in participants with CI-DME. Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. Participants will be randomized into each arm group (1:1:1) and total duration of the study will be approximately 32 weeks.

Medications: Provided by the study. RO6867461, Ranibizumab

Ages Eligible for Study: 18 Years and older

Completed Studies

Clearside – TOPAZ

Retinal Vein Occlusion

Protocol Title: A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in combination with an intravitreal anti-VEGF agent in subjects with retinal vein occlusion

Purpose: To demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone

Medications: Provided by the study. Lucentis and CLS-TA

Ages Eligible for study: 18 Years and older

Allergan – Sequoia

Ohr Pharmaceutical Inc.

Neovascular Age-Related Macular Degeneration

Hoffmann-La Roche – BOULEVARD

Center-Involving Diabetic Macular Edema (CI-DME)

Iconic Therapeutics, Inc.

Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Protocol Title: Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (EMERGE)

Purpose: The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

ThromboGenics

Symptomatic Vitreomacular Adhesion

Protocol Title: Ocriplasmin Research to Better Inform Treatment (ORBIT)

Purpose: This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites

Kato Pharmaceuticals, Inc.

Vitreomacular Attachment, Vitreomacular Traction, Vitreomacular Adhesion

Protocol Title: A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment

Purpose: This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion

Pfizer

Macular Edema, Diabetic

Protocol Title: A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

Purpose: The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema. The current treatment option for these subjects is an injection directly into the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and might be able to provide an alternative mechanism to treat Diabetic Macular Edema.

Lpath, Inc.

Exudative Age-related Macular Degeneration

Protocol Title: Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD (Nexus)

Purpose: The purpose of the study is to determine the safety and efficacy of 4 monthly injections of iSONEP given alone or in combination with Lucentis, Avastin or Eylea in subjects with wet Age-related Macular Degeneration (AMD). iSONEP not only has an anti-permeability effect, but also has anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. The drug may therefore have the ability to achieve better visual outcomes than Lucentis, Avastin or Eylea, particularly in those subjects who do not demonstrate a robust response to Lucentis, Avastin or Eylea after several monthly injections. Further, the combination of Lucentis, Avastin or Eylea and iSONEP may be additive or synergistic. By inhibiting the multiple mechanisms that contribute to exudative-AMD-related vision loss, better visual outcomes may be possible than with Lucentis, Avastin or Eylea alone.