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. 2017 Jun 22;2017(6):CD007419. doi: 10.1002/14651858.CD007419.pub5

NCT02348918

Trial name or 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® and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema
Methods Parallel group RCT
Participants DMO participants
Interventions Experimental: Luminate 1.0 mg group

  • Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with PRN Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if PRN Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks


Experimental: Luminate 2.0 mg group

  • Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with PRN Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if PRN Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks


Experimental: Luminate 3.0 mg group

  • Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with PRN Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if PRN Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks


Active Comparator: Avastin® group

  • Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with PRN Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if PRN Avastin is not required; sham laser treatment will be administered at baseline and at 16 weeks


Active Comparator: focal laser photocoagulation group

  • Focal laser photocoagulation performed at baseline (Day 0) with possible PRN laser retreatment at week 16. Sham intravitreal injections will be performed at baseline (Day 0), 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 weeks
Outcomes Primary outcome measures:

  • Change in OCT CSFT at Week 24 (time frame: 24 weeks)

  • The primary efficacy outcome is OCT CSFT at Week 24 as compared to baseline


Secondary outcome measures:

  • Change in BCVA at Week 24 (time frame: 24 weeks)

  • Secondary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Starting date October 2014 Estimated study completion date: March 2016 Estimated primary completion date: December 2015 (final data collection date for primary outcome measure)
Contact information Allegro Ophthalmics, LLC
Notes This study is recruiting participants; (status checked on ClinicalTrials.gov on 5 Dec. 2016)