Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Luminate 1.0mg; Luminate 2.0mg; Luminate 3.0mg; Avastin; Luminate 0.5mg
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.