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Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT00658619
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : April 26, 2013
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Macular Degeneration
Interventions: Drug: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
Other: Sham (no implant)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Stage 1 of the study was a patient-masked, dose-escalation, paired-eye comparison and the Investigator was not masked. Stage 2 was a parallel-group, sham-controlled, paired-eye comparison. Investigators were masked as to dose received for patients in the active treatment groups. No patients from Stage 1 were enrolled in Stage 2.

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant Stage 1 Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 1 Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
400 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Sham (no Implant) Stage 2 Stage 2: sham in both eyes on Day 1 and Month 6.

Participant Flow:   Overall Study
    400 µg Brimonidine Tartrate Implant Stage 1   200 µg Brimonidine Tartrate Implant Stage 1   400 µg Brimonidine Tartrate Implant Stage 2   200 µg Brimonidine Tartrate Implant Stage 2   Sham (no Implant) Stage 2
STARTED   3   3   41   49   23 
COMPLETED   3   2   31   37   21 
NOT COMPLETED   0   1   10   12   2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant Stage 1 Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 1 Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
400 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Sham (no Implant) Stage 2 Stage 2: sham in both eyes on Day 1 and Month 6.
Total Total of all reporting groups

Baseline Measures
   400 µg Brimonidine Tartrate Implant Stage 1   200 µg Brimonidine Tartrate Implant Stage 1   400 µg Brimonidine Tartrate Implant Stage 2   200 µg Brimonidine Tartrate Implant Stage 2   Sham (no Implant) Stage 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   41   49   23   119 
Age 
[Units: Years]
Mean (Standard Deviation)
 85.0  (3.61)   79.0  (3.00)   75.6  (8.78)   77.0  (9.13)   78.4  (5.80)   77.0  (8.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      3 100.0%      2  66.7%      27  65.9%      28  57.1%      12  52.2%      72  60.5% 
Male      0   0.0%      1  33.3%      14  34.1%      21  42.9%      11  47.8%      47  39.5% 


  Outcome Measures

1.  Primary:   Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye   [ Time Frame: Baseline, Month 12 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Measure Description Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Time Frame Baseline, Month 12  

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.
Intent-to-Treat: All randomized patients who participated in Stage 2

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Sham (no Implant) Stage 2 Stage 2: sham in both eyes on Day 1 and Month 6.

Measured Values
   400 µg Brimonidine Tartrate Implant Stage 2   200 µg Brimonidine Tartrate Implant Stage 2   Sham (no Implant) Stage 2 
Participants Analyzed   41   49   23 
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye 
[Units: Disc Area]
Mean (Standard Deviation)
     
Baseline   6.219  (3.9524)   6.897  (4.6397)   5.526  (4.7890) 
Change from Baseline at Month 12   0.898  (0.7520)   1.006  (0.7858)   1.239  (1.1645) 

No statistical analysis provided for Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye



2.  Secondary:   Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye   [ Time Frame: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Measure Description Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).
Time Frame Baseline, Month 3, Month 6, Month 9, Month 18, Month 24  

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.
Intent-to-Treat: All randomized patients who participated in Stage 2

Reporting Groups
  Description
400 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 2 Stage 2: 200 µg brimonidine tartrate implant in study eye and sham in fellow eye on Day 1 and Month 6.
Sham (no Implant) Stage 2 Stage 2: sham in both eyes on Day 1 and Month 6.

Measured Values
   400 µg Brimonidine Tartrate Implant Stage 2   200 µg Brimonidine Tartrate Implant Stage 2   Sham (no Implant) Stage 2 
Participants Analyzed   41   49   23 
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye 
[Units: Disc Area]
Mean (Standard Deviation)
     
Baseline   6.219  (3.9524)   6.897  (4.6397)   5.526  (4.7890) 
Change from Baseline at Month 3   0.182  (0.3353)   0.117  (0.6612)   0.399  (0.3713) 
Change from Baseline at Month 6   0.482  (0.6325)   0.570  (0.5749)   0.609  (0.5474) 
Change from Baseline at Month 9   0.641  (0.6847)   0.798  (0.6424)   0.857  (0.7267) 
Change from Baseline at Month 18   1.306  (1.0164)   1.413  (1.0291)   1.697  (1.4185) 
Change from Baseline at Month 24   1.744  (1.4010)   1.991  (1.4469)   2.178  (1.7042) 

No statistical analysis provided for Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye



3.  Secondary:   Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye   [ Time Frame: Baseline, 24 Months ]

4.  Secondary:   Change From Baseline in Contrast Sensitivity in the Study Eye   [ Time Frame: Baseline, 24 Months ]

5.  Secondary:   Change From Baseline in Reading Speed in the Study Eye   [ Time Frame: Baseline, 24 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00658619     History of Changes
Other Study ID Numbers: 190342-032D
First Submitted: April 11, 2008
First Posted: April 15, 2008
Results First Submitted: March 13, 2013
Results First Posted: April 26, 2013
Last Update Posted: August 21, 2018