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Efficacy and Safety Study of iSONEP With & Without Lucentis/Avastin/Eylea to Treat Wet AMD (Nexus)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lpath, Inc.
ClinicalTrials.gov Identifier:
NCT01414153
First received: August 9, 2011
Last updated: August 22, 2016
Last verified: August 2016
Results First Received: June 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Exudative Age-related Macular Degeneration
Interventions: Drug: 4.0 mg iSONEP
Drug: 0.5 mg iSONEP
Drug: 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea
Drug: sham injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Monotherapy 4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
0.5 mg iSONEP & Lucentis/Avastin/Eylea 0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
4.0 mg iSONEP & Lucentis/Avastin/Eylea 4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
Lucentis or Avastin or Eylea 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months

Participant Flow:   Overall Study
    Monotherapy   0.5 mg iSONEP & Lucentis/Avastin/Eylea   4.0 mg iSONEP & Lucentis/Avastin/Eylea   Lucentis or Avastin or Eylea
STARTED   38   40   39   41 
COMPLETED   30   38   35   37 
NOT COMPLETED   8   2   4   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Monotherapy 4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
0.5 mg iSONEP & Lucentis/Avastin/Eylea 0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
4.0 mg iSONEP & Lucentis/Avastin/Eylea 4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
Lucentis or Avastin or Eylea 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
Total Total of all reporting groups

Baseline Measures
   Monotherapy   0.5 mg iSONEP & Lucentis/Avastin/Eylea   4.0 mg iSONEP & Lucentis/Avastin/Eylea   Lucentis or Avastin or Eylea   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   40   39   41   158 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.1  (7.53)   77.2  (7.43)   77.6  (7.86)   76.5  (7.95)   76.8  (7.65) 
Gender 
[Units: Participants]
         
Female   22   20   21   20   83 
Male   16   20   18   21   75 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   2   3   2   3   10 
Not Hispanic or Latino   36   37   37   38   148 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   0   0   1   1 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   2   0   0   0   2 
White   36   39   39   40   154 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   1   0   0   1 
Region of Enrollment 
[Units: Participants]
         
United States   38   40   39   41   158 
Best Corrected Visual Acuity (ETDRS) [1] 
[Units: Letters]
Mean (Standard Deviation)
 56.2  (15.84)   58.7  (10.75)   61.3  (9.20)   63.2  (7.88)   59  (11.45) 
[1] Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score (more letters read) represents better functioning.
Choroidal neovascularization (CNV) Lesion Type 
[Units: Percentage of participants]
         
Predominantly Classic   10.5   15.0   12.8   22.0   60.3 
Minimally Classic   5.3   5.0   5.1   7.3   22.7 
Occult   76.3   77.5   79.5   61.0   294.3 
Unreadable   5.3   0.0   0.0   2.4   7.7 
Missing   2.6   2.5   2.6   7.3   15 


  Outcome Measures
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1.  Primary:   Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)   [ Time Frame: Baseline to Day 120 ]

2.  Secondary:   Mean Change in Central Subfield Retinal Thickness   [ Time Frame: Baseline to Day 120 ]

3.  Secondary:   Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).   [ Time Frame: Baseline to Day 120 ]

4.  Secondary:   Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.   [ Time Frame: Baseline to Day 120 ]

5.  Secondary:   Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.   [ Time Frame: Baseline to Day 120 ]

6.  Secondary:   Proportion of Subjects With ETDRS BCVA of 20/40 or Better.   [ Time Frame: Baseline to Day 120 ]

7.  Secondary:   Proportion of Subjects With Adverse Events.   [ Time Frame: Baseline to Day 120 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan E. Hazel
Organization: Lpath, Inc.
phone: 858-926-3205
e-mail: shazel@lpath.com



Responsible Party: Lpath, Inc.
ClinicalTrials.gov Identifier: NCT01414153     History of Changes
Other Study ID Numbers: LT1009-Oph-003
Study First Received: August 9, 2011
Results First Received: June 27, 2016
Last Updated: August 22, 2016
Health Authority: United States: Food and Drug Administration