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

Diabetic Macular Edema Clinical Trial

Official title:

A Phase 2 Randomized, Controlled, Double-Masked, Multicenter 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 (DME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348918
• Other study ID #: DME 202B
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2014
• Est. completion date: June 13, 2017

Study information

• Verified date: December 2018
• Source: Allegro Ophthalmics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema

• Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).

Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 13, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Luminate 1.0mg

• Luminate 2.0mg

• Luminate 3.0mg

• Avastin

• Luminate 0.5mg

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Allegro Ophthalmics, LLC	Duke University, Trial Runners, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BCVA at Week 24	Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline	Value of 24 Weeks minus baseline value