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Trial record 32 of 41 for:    FROVATRIPTAN

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

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.
 
ClinicalTrials.gov Identifier: NCT02348918
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Trial Runners, LLC
Duke University
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: Luminate 1.0mg
Drug: Luminate 2.0mg
Drug: Luminate 3.0mg
Drug: Avastin
Drug: Luminate 0.5mg
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Hide Arm/Group Description

Stage 1- 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.

Luminate 1.0mg

Stage 1 -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.

Luminate 2.0mg

Stage 1- 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.

Luminate 3.0mg

Stage 1- 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.

Avastin

Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Luminate 0.5mg

Period Title: Overall Study
Started 39 33 42 24 19 17 13 16 15
Completed 39 33 42 24 19 17 13 16 15
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT Total
Hide Arm/Group Description

Stage 1- 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.

Luminate 1.0mg

Stage 1 -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.

Luminate 2.0mg

Stage 1- 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.

Luminate 3.0mg

Stage 1- 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.

Avastin

Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Luminate 0.5mg

Total of all reporting groups
Overall Number of Baseline Participants 39 33 42 24 19 17 13 16 15 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 33 participants 42 participants 24 participants 19 participants 17 participants 13 participants 16 participants 15 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  53.8%
19
  57.6%
29
  69.0%
15
  62.5%
10
  52.6%
10
  58.8%
10
  76.9%
12
  75.0%
9
  60.0%
135
  61.9%
>=65 years
18
  46.2%
14
  42.4%
13
  31.0%
9
  37.5%
9
  47.4%
7
  41.2%
3
  23.1%
4
  25.0%
6
  40.0%
83
  38.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 33 participants 42 participants 24 participants 19 participants 17 participants 13 participants 16 participants 15 participants 218 participants
62.9  (9.05) 61  (9.91) 63.8  (9.45) 60.3  (8.83) 67.1  (10.47) 65.5  (9.41) 60.1  (10.92) 60.5  (8.29) 62.1  (9.35) 62.3  (9.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 33 participants 42 participants 24 participants 19 participants 17 participants 13 participants 16 participants 15 participants 218 participants
Female
23
  59.0%
13
  39.4%
17
  40.5%
6
  25.0%
10
  52.6%
12
  70.6%
7
  53.8%
8
  50.0%
10
  66.7%
106
  48.6%
Male
16
  41.0%
20
  60.6%
25
  59.5%
18
  75.0%
9
  47.4%
5
  29.4%
6
  46.2%
8
  50.0%
5
  33.3%
112
  51.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 33 participants 42 participants 24 participants 19 participants 17 participants 13 participants 16 participants 15 participants 218 participants
white
33
  84.6%
29
  87.9%
38
  90.5%
17
  70.8%
17
  89.5%
15
  88.2%
7
  53.8%
13
  81.3%
12
  80.0%
181
  83.0%
Black or African American
4
  10.3%
1
   3.0%
3
   7.1%
3
  12.5%
1
   5.3%
1
   5.9%
5
  38.5%
1
   6.3%
2
  13.3%
21
   9.6%
Asian
1
   2.6%
1
   3.0%
0
   0.0%
3
  12.5%
0
   0.0%
1
   5.9%
1
   7.7%
2
  12.5%
0
   0.0%
9
   4.1%
Other
1
   2.6%
2
   6.1%
0
   0.0%
1
   4.2%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   2.3%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
2
   0.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 33 participants 42 participants 24 participants 19 participants 17 participants 13 participants 16 participants 15 participants 218 participants
39
 100.0%
33
 100.0%
42
 100.0%
24
 100.0%
19
 100.0%
17
 100.0%
13
 100.0%
16
 100.0%
15
 100.0%
218
 100.0%
1.Primary Outcome
Title Change in BCVA at Week 24
Hide Description Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Time Frame Value of 24 Weeks minus baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Hide Arm/Group Description:

Stage 1- 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.

Luminate 1.0mg

Stage 1 -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.

Luminate 2.0mg

Stage 1- 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.

Luminate 3.0mg

Stage 1- 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.

Avastin

Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Luminate 0.5mg

Overall Number of Participants Analyzed 39 33 42 24 19 17 13 16 15
Mean (Standard Error)
Unit of Measure: Letters on ETDRS eye chart
5.2  (3) 2.7  (3) -1.5  (3) 7  (3) 7.1  (3) 4.6  (3) 1.4  (3) 3.9  (3) 6.7  (3)
Time Frame The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Hide Arm/Group Description

Stage 1- 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.

Luminate 1.0mg

Stage 1 -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.

Luminate 2.0mg

Stage 1- 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.

Luminate 3.0mg

Stage 1- 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.

Avastin

Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Luminate 1.0mg

Avastin

Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT

Avastin

Luminate 0.5mg

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Luminate 0.5mg

All-Cause Mortality
Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/39 (2.56%)      0/33 (0.00%)      1/42 (2.38%)      1/24 (4.17%)      0/19 (0.00%)      0/17 (0.00%)      0/13 (0.00%)      0/16 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/39 (20.51%)      3/33 (9.09%)      6/42 (14.29%)      3/24 (12.50%)      2/19 (10.53%)      1/17 (5.88%)      1/13 (7.69%)      2/16 (12.50%)      3/15 (20.00%)    
Cardiac disorders                   
Cardiac disorders  1  2/39 (5.13%)  0/33 (0.00%)  1/42 (2.38%)  0/24 (0.00%)  2/19 (10.53%)  0/17 (0.00%)  0/13 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Eye disorders                   
eye disorders  1  3/39 (7.69%)  1/33 (3.03%)  3/42 (7.14%)  1/24 (4.17%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
General disorders                   
general disorders  1  0/39 (0.00%)  0/33 (0.00%)  1/42 (2.38%)  1/24 (4.17%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Infections and infestations                   
Infections and infestations  1  2/39 (5.13%)  1/33 (3.03%)  1/42 (2.38%)  1/24 (4.17%)  0/19 (0.00%)  1/17 (5.88%)  0/13 (0.00%)  0/16 (0.00%)  2/15 (13.33%) 
Metabolism and nutrition disorders                   
Metabolism and nutritional disorders  1  0/39 (0.00%)  0/33 (0.00%)  2/42 (4.76%)  0/24 (0.00%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders                   
Musculoskeletal and connective tissue disorders  1  0/39 (0.00%)  0/33 (0.00%)  1/42 (2.38%)  0/24 (0.00%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Neoplasms benign malignant and unspecified  1  0/39 (0.00%)  1/33 (3.03%)  0/42 (0.00%)  0/24 (0.00%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  2/15 (13.33%) 
Nervous system disorders                   
Nervous system disorder  1  1/39 (2.56%)  0/33 (0.00%)  1/42 (2.38%)  1/24 (4.17%)  0/19 (0.00%)  0/17 (0.00%)  1/13 (7.69%)  0/16 (0.00%)  0/15 (0.00%) 
Renal and urinary disorders                   
Renal and urinary disorders  1  0/39 (0.00%)  0/33 (0.00%)  0/42 (0.00%)  0/24 (0.00%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  1/16 (6.25%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Respitatory, thoracic and mediastinal  1  1/39 (2.56%)  0/33 (0.00%)  1/42 (2.38%)  1/24 (4.17%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Surgical and medical procedures                   
Surgical and medical procedures  1  0/39 (0.00%)  0/33 (0.00%)  1/42 (2.38%)  0/24 (0.00%)  0/19 (0.00%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
Vascular disorders                   
Vascular disorders  1  0/39 (0.00%)  0/33 (0.00%)  0/42 (0.00%)  0/24 (0.00%)  1/19 (5.26%)  0/17 (0.00%)  0/13 (0.00%)  0/16 (0.00%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Luminate 1.0mg Group Luminate 2.0mg Group Luminate 3.0mg Group Avastin® Group Avastin Then Luminate 1.0 mg IVT + Sham Injection Avastin Then Luminate 0.5 mg IVT + Sham Injection Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Avastin 1.25 mg + Sham IVT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/39 (71.79%)      20/33 (60.61%)      25/42 (59.52%)      16/24 (66.67%)      10/19 (52.63%)      5/17 (29.41%)      6/13 (46.15%)      7/16 (43.75%)      3/15 (20.00%)    
Blood and lymphatic system disorders                   
Blood and Lymphatic  1  2/39 (5.13%)  2 0/33 (0.00%)  0 0/42 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 0/13 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Cardiac disorders                   
Cardiac disorders  1  3/39 (7.69%)  4 0/33 (0.00%)  0 0/42 (0.00%)  0 0/24 (0.00%)  0 2/19 (10.53%)  2 0/17 (0.00%)  0 0/13 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Eye disorders                   
eye disorders  1  17/39 (43.59%)  18 9/33 (27.27%)  9 11/42 (26.19%)  20 7/24 (29.17%)  19 6/19 (31.58%)  7 1/17 (5.88%)  1 4/13 (30.77%)  9 5/16 (31.25%)  6 1/15 (6.67%)  1
Gastrointestinal disorders                   
gastrointestinal disorders  1  0/39 (0.00%)  0 3/33 (9.09%)  3 4/42 (9.52%)  4 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations                   
infections and infestations  1  6/39 (15.38%)  6 5/33 (15.15%)  5 4/42 (9.52%)  5 3/24 (12.50%)  3 1/19 (5.26%)  1 2/17 (11.76%)  2 2/13 (15.38%)  3 1/16 (6.25%)  1 0/15 (0.00%)  0
Injury, poisoning and procedural complications                   
Injury, poisoning and procedural complications  1  5/39 (12.82%)  5 3/33 (9.09%)  3 0/42 (0.00%)  0 3/24 (12.50%)  3 0/19 (0.00%)  0 1/17 (5.88%)  1 0/13 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Investigations                   
Investigations  1  0/39 (0.00%)  0 0/33 (0.00%)  0 4/42 (9.52%)  4 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 0/13 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Metabolism and nutrition disorders                   
Metabolism and nutritional disorders  1  2/39 (5.13%)  2 0/33 (0.00%)  0 4/42 (9.52%)  5 2/24 (8.33%)  3 0/19 (0.00%)  0 1/17 (5.88%)  2 0/13 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
musculoskeletal and connective tissue  1  2/39 (5.13%)  3 2/33 (6.06%)  2 0/42 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/17 (0.00%)  0 0/13 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders                   
Nervous system disorders  1  0/39 (0.00%)  0 0/33 (0.00%)  0 0/42 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 0/13 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1
Psychiatric disorders                   
psychiatric disorders  1  0/39 (0.00%)  0 0/33 (0.00%)  0 0/42 (0.00%)  0 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders                   
Renal and urinary disorders  1  0/39 (0.00%)  0 0/33 (0.00%)  0 0/42 (0.00%)  0 2/24 (8.33%)  2 0/19 (0.00%)  0 0/17 (0.00%)  0 0/13 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders                   
skin and subcutaneous tissue disorders  1  0/39 (0.00%)  0 0/33 (0.00%)  0 2/42 (4.76%)  2 0/24 (0.00%)  0 0/19 (0.00%)  0 0/17 (0.00%)  0 1/13 (7.69%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders                   
Vascular disorders  1  4/39 (10.26%)  4 2/33 (6.06%)  2 0/42 (0.00%)  0 0/24 (0.00%)  0 1/19 (5.26%)  1 0/17 (0.00%)  0 0/13 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA (15.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator will submit to Sponsor a copy of the proposed publication or presentation and the name of the scientific journal or forum to which it will be submitted- at least ninety (90) days prior to the submission.Investigator shall comply with Sponsor's request to delete references to Confidential Information,in any such paper or presentation and agrees to withhold publication or presentation of same for an additional ninety (90) days in order to permit Sponsor to obtain patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Allegro Ophthalmics, LLC
Phone: 949-940-8130
EMail: info@allegroeye.com
Layout table for additonal 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
Results First Submitted: August 31, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018