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Trial record 1 of 1 for:    DME Allegro
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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Allegro Ophthalmics, LLC.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02348918
First Posted: January 28, 2015
Last Update Posted: January 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Trial Runners, LLC
Duke University
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC
  Purpose
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

Condition Intervention Phase
Diabetic Macular Edema Drug: Luminate 1.0mg Drug: Luminate 2.0mg Drug: Luminate 3.0mg Drug: Avastin Device: Focal laser photocoagulation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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® and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Allegro Ophthalmics, LLC:

Primary Outcome Measures:
  • Change in OCT (Optical coherence tomagraphy) Central Subfield Thickness at Week 24 [ Time Frame: 24 Weeks ]
    The primary efficacy outcome is OCT central subfield thickness 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


Estimated Enrollment: 150
Study Start Date: October 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Luminate 1.0mg 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.
Drug: Luminate 1.0mg
Experimental: Luminate 2.0mg 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.
Drug: Luminate 2.0mg
Experimental: Luminate 3.0mg group
Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 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.
Drug: Luminate 3.0mg
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.
Drug: Avastin
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.
Device: Focal laser photocoagulation

Detailed Description:

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

- 150 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups, i.e., one of three doses of Luminate intravitreal injection or Avastin intravitreal injection or focal laser photocoagulation. Subjects will be followed monthly for 24 weeks (6 months)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age or older.
  2. Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
  3. 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.
  4. 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.
  5. In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
  6. 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.

  7. Willing and able to return for all study visits.
  8. Able to meet the extensive post-op evaluation regimen.
  9. Understands and signs the informed consent form.

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348918


Contacts
Contact: Hampar Karageozian (949) 940 - 8130
Contact: Vicken Karageozian (949) 940 - 8130

Locations
United States, Arizona
Associated Retina Consultants Recruiting
Pheonix, Arizona, United States, 85020
Contact: Kwong, Dr.    602-216-1152      
United States, California
Retina Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: David Boyer, Dr.    310-854-6201      
Northern California Retina Vitreous Associates Recruiting
Mountain View, California, United States, 94040
Contact: James Palmer, Dr.    650-966-9307      
West Coast Retina Not yet recruiting
San Francisco, California, United States, 94109
Contact: Arthur Fu, Dr.    415-975-0867      
Orange County Retina Medical Group Recruiting
Santa Ana, California, United States, 92705
Contact: Sanford Chen, Dr.    714-560-8401      
United States, Connecticut
New England Retina Associates Not yet recruiting
New London, Connecticut, United States, 06320
Contact: Nauman Chaudhry, Dr.    860-444-1827      
United States, Florida
Florida Eye Clinic Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: Robert Feldman, Dr.    407-834-7776      
Retina Specialty Institute Not yet recruiting
Pensacola, Florida, United States, 32503
Contact: Sunil Gupta, Dr.    888-256-9591      
Center for Retina and Macular Disease Recruiting
Winter Haven, Florida, United States, 33880
Contact: Michael Tolentino, Dr.    863-297-5400      
United States, Maryland
Wilmer Eye Institute at John Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Syed Shah, Dr.    410-955-5080      
United States, Michigan
TLC Eye Group Recruiting
Jackson, Michigan, United States, 49202
Contact: Carmelina Gordon, Dr.    517-841-3034      
United States, New York
Island Retina Recruiting
Shirley, New York, United States, 11967
Contact: Pamela Weber, Dr.    631-904-2415      
United States, North Carolina
Charlotte EENT Associates Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Andrew Antoszyk, Dr.    704-295-3000      
United States, South Dakota
Black Hills Regional Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Prema Abraham, Dr.    605-719-3280      
United States, Texas
Austin Retina Associates Recruiting
Austin, Texas, United States, 78705
Contact: Robert Wong, Dr.    512-451-0103      
Retina Consultant of Houston Recruiting
Houston, Texas, United States, 77098
Contact: David Brown, Dr.    800-833-5921      
United States, Washington
Spokane Eye Clinical Research Recruiting
Spokane, Washington, United States, 99204
Contact: Robert Wirthlin, Dr.    509-747-2635      
Sponsors and Collaborators
Allegro Ophthalmics, LLC
Trial Runners, LLC
Duke University
Investigators
Study Director: Vicken Karageozian Cheif Medical Officer
  More Information

Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02348918     History of Changes
Other Study ID Numbers: DME 202B
First Submitted: January 12, 2015
First Posted: January 28, 2015
Last Update Posted: January 28, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents