NCT02348918

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Allegro Ophthalmics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Luminate 1.0mg
DRUG	Luminate 2.0mg
DRUG	Luminate 3.0mg
DRUG	Avastin
DRUG	Luminate 0.5mg

Timeline

• Start date: 2014-10-13
• Primary completion: 2017-05-16
• Completion: 2017-06-13
• First posted: 2015-01-28
• Last updated: 2018-12-07
• Results posted: 2018-12-07

Locations

17 sites across 1 country: United States