Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema

Key facts

Study ID

NCT02348918

Run by

Allegro Ophthalmics, LLC

People needed

218

Starts

2014-10-13

Expected to finish

2017-06-13

Last updated by the study team

2018-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 18 years of age or older.
• Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
• Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
• Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
• In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
• Intra-Ocular Pressure (IOP) is under control (i.e., IOP
• ≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
• Willing and able to return for all study visits.
• Able to meet the extensive post-op evaluation regimen.
• Understands and signs the informed consent form.

You may not qualify if…

• Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
• Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
• Screening HgA1c blood test > 10.0
• Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
• A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
• History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.
• Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
• Previous pars plana vitrectomy in the study eye
• Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
• YAG laser treatment in the study eye in last 30 days prior to study enrollment.
• High myopia in the study eye, with a spherical equivalent of >8.00D at screening
• Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
• Chronic or recurrent uveitis.
• Ongoing ocular infection or inflammation in either eye.
• A history of cataract surgery complications/vitreous loss in the study eye.
• Congenital eye malformations in the study eye.
• A history of penetrating ocular trauma in the study eye.
• Mentally handicapped.
• Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
• Nursing female.
• Currently participating in any other clinical research study.
• Contraindication to the study medication.

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• West Coast Retina — San Francisco, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• New England Retina Associates — New London, Connecticut, United States
• Florida Eye Clinic — Altamonte Springs, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Wilmer Eye Institute at John Hopkins University — Baltimore, Maryland, United States
• TLC Eye Group — Jackson, Michigan, United States
• Island Retina — Shirley, New York, United States
• Charlotte EENT Associates — Charlotte, North Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Austin Retina Associates — Austin, Texas, United States
• Retina Consultant of Houston — Houston, Texas, United States
• Spokane Eye Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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