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Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

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ClinicalTrials.gov Identifier: NCT00693485
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : April 24, 2013
Last Update Posted : April 24, 2013
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 Glaucoma, Open-Angle
Interventions Drug: 400 ug Brimonidine Implant
Drug: 200 ug Brimonidine Implant
Drug: Sham (no implant)
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Hide Arm/Group Description 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Period Title: Overall Study
Started 25 21 24
Completed 25 19 24
Not Completed 0 2 0
Arm/Group Title 400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant) Total
Hide Arm/Group Description 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. Total of all reporting groups
Overall Number of Baseline Participants 25 21 24 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 24 participants 70 participants
<45 years 0 0 1 1
Between 45 and 65 years 9 11 12 32
>65 years 16 10 11 37
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 21 participants 24 participants 70 participants
Female
12
  48.0%
12
  57.1%
10
  41.7%
34
  48.6%
Male
13
  52.0%
9
  42.9%
14
  58.3%
36
  51.4%
Mean Deviation from Normal Visual Field Using the HFA 24-2   [1] 
Mean (Full Range)
Unit of measure:  Decibels (db)
Number Analyzed 25 participants 21 participants 24 participants 70 participants
-15.5
(-28.2 to -6.4)
-14.6
(-24.3 to -10.1)
-17.9
(-30.9 to -9.4)
-16.0
(-30.9 to -6.4)
[1]
Measure Description: Mean deviation is the difference between the expected normal visual field compared to the patient's visual field.
1.Primary Outcome
Title Percentage of Patients With a Visual Field Improvement in the Study Eye
Hide Description Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all patients who received 1 dose of study medication or sham treatment
Arm/Group Title 400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Hide Arm/Group Description:
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Overall Number of Participants Analyzed 25 21 24
Measure Type: Number
Unit of Measure: Percentage of Patients
12.0 9.5 4.2
2.Secondary Outcome
Title Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Hide Description BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all patients who received 1 dose of study medication or sham treatment
Arm/Group Title 400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Hide Arm/Group Description:
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Overall Number of Participants Analyzed 25 21 24
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 76.0  (7.82) 80.6  (6.20) 77.3  (7.71)
Change from Baseline at Month 6 2.8  (3.68) -2.2  (18.35) 0.3  (5.18)
Time Frame [Not Specified]
Adverse Event Reporting Description For Ocular Adverse Events (AEs), only those in the study eye are reported in the "Other Adverse Events" section. For Serious Adverse Events (SAEs), all ocular events were reported in the SAE section, regardless of the eye.
 
Arm/Group Title 400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Hide Arm/Group Description 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
All-Cause Mortality
400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/25 (12.00%)   5/21 (23.81%)   1/24 (4.17%) 
Cardiac disorders       
Arteriospasm coronary  1  0/25 (0.00%)  1/21 (4.76%)  0/24 (0.00%) 
Eye disorders       
Cataract  1  0/25 (0.00%)  1/21 (4.76%)  0/24 (0.00%) 
Infections and infestations       
Cellulitis  1  1/25 (4.00%)  0/21 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications       
Concussion  1  0/25 (0.00%)  1/21 (4.76%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/25 (0.00%)  1/21 (4.76%)  0/24 (0.00%) 
Osteoarthritis  1  0/25 (0.00%)  0/21 (0.00%)  1/24 (4.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma  1  0/25 (0.00%)  1/21 (4.76%)  0/24 (0.00%) 
Nervous system disorders       
Syncope * 1  1/25 (4.00%)  0/21 (0.00%)  0/24 (0.00%) 
Vascular disorders       
Hypertension * 1  1/25 (4.00%)  0/21 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
400 ug Brimonidine Implant 200 ug Brimonidine Implant Sham (no Implant)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/25 (72.00%)   19/21 (90.48%)   20/24 (83.33%) 
Eye disorders       
Conjunctival haemorrhage  1  6/25 (24.00%)  2/21 (9.52%)  3/24 (12.50%) 
Punctate keratitis  1  4/25 (16.00%)  2/21 (9.52%)  1/24 (4.17%) 
Conjunctival Hyperaemia  1  3/25 (12.00%)  3/21 (14.29%)  3/24 (12.50%) 
Eye Irritation * 1  3/25 (12.00%)  0/21 (0.00%)  2/24 (8.33%) 
Eye Pain * 1  3/25 (12.00%)  1/21 (4.76%)  0/24 (0.00%) 
Blepharitis  1  2/25 (8.00%)  0/21 (0.00%)  0/24 (0.00%) 
Lacrimation Increased * 1  1/25 (4.00%)  1/21 (4.76%)  2/24 (8.33%) 
Conjunctivitis  1  1/25 (4.00%)  2/21 (9.52%)  1/24 (4.17%) 
Foreign Body Sensation in Eyes * 1  1/25 (4.00%)  2/21 (9.52%)  0/24 (0.00%) 
Vitreous Detachment  1  0/25 (0.00%)  1/21 (4.76%)  2/24 (8.33%) 
Cataract  1  0/25 (0.00%)  1/21 (4.76%)  3/24 (12.50%) 
Retinal Pigmentation  1  0/25 (0.00%)  2/21 (9.52%)  0/24 (0.00%) 
Gastrointestinal disorders       
Vomiting * 1  2/25 (8.00%)  0/21 (0.00%)  0/24 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/25 (0.00%)  0/21 (0.00%)  2/24 (8.33%) 
Infections and infestations       
Sinusitis  1  1/25 (4.00%)  2/21 (9.52%)  3/24 (12.50%) 
Upper Respiratory Tract Infection  1  0/25 (0.00%)  2/21 (9.52%)  0/24 (0.00%) 
Investigations       
Intraocular pressure increased  1  3/25 (12.00%)  2/21 (9.52%)  2/24 (8.33%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  0/25 (0.00%)  0/21 (0.00%)  2/24 (8.33%) 
Nervous system disorders       
Headache * 1  4/25 (16.00%)  1/21 (4.76%)  0/24 (0.00%) 
Syncope * 1  2/25 (8.00%)  0/21 (0.00%)  0/24 (0.00%) 
Psychiatric disorders       
Anxiety * 1  2/25 (8.00%)  0/21 (0.00%)  0/24 (0.00%) 
Vascular disorders       
Hypertension  1  3/25 (12.00%)  2/21 (9.52%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 10.0
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00693485     History of Changes
Other Study ID Numbers: 190342-030D
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: March 13, 2013
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013