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Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

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ClinicalTrials.gov Identifier: NCT00972374
Recruitment Status : Completed
First Posted : September 4, 2009
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 Rhegmatogenous Macula-off Retinal Detachment
Interventions Drug: 400 ug Brimonidine Implant
Drug: 200 ug Brimonidine Implant
Other: Sham (no implant)
Enrollment 44
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 on Day 1 in the study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Period Title: Overall Study
Started 15 15 14
Completed 13 15 13
Not Completed 2 0 1
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 on Day 1 in the study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. Total of all reporting groups
Overall Number of Baseline Participants 15 15 14 44
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 14 participants 44 participants
54.2  (17.12) 54.3  (20.36) 56.1  (15.19) 54.9  (17.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 14 participants 44 participants
Female
6
  40.0%
5
  33.3%
5
  35.7%
16
  36.4%
Male
9
  60.0%
10
  66.7%
9
  64.3%
28
  63.6%
1.Primary Outcome
Title Percentage of Patients With at Least a 15-Letter Increase 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). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
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 on Day 1 in the study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Overall Number of Participants Analyzed 15 15 14
Measure Type: Number
Unit of Measure: Percentage of Patients
6.7 6.7 0
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 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
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 on Day 1 in the study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Overall Number of Participants Analyzed 15 15 14
Mean (Standard Deviation)
Unit of Measure: Number of Letters Read Correctly
Baseline 46.6  (13.69) 53.3  (8.46) 50.3  (10.92)
Change from Baseline at Month 3 6.0  (6.23) 3.1  (6.78) 4.8  (4.64)
3.Other Pre-specified Outcome
Title Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit
Hide Description IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat: all randomized patients
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 on Day 1 in the study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Overall Number of Participants Analyzed 15 15 14
Measure Type: Number
Unit of Measure: Percentage of Patients
20.0 26.7 28.6
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 are 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 on Day 1 in the study eye. 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. Sham Posterior Segment Drug Delivery system on Day 1 in the 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   0/15 (0.00%)   2/15 (13.33%)   2/14 (14.29%) 
Cardiac disorders       
Myocardial Infarction  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders       
Haemorrhoids  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate Cancer [y]  1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Surgical and medical procedures       
Strabismus Correction  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
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   7/15 (46.67%)   12/15 (80.00%)   9/14 (64.29%) 
Cardiac disorders       
Arrhythmia  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Myocardial Infarction  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Eye disorders       
Conjunctival Haemorrhage  1  3/15 (20.00%)  1/15 (6.67%)  2/14 (14.29%) 
Conjunctival Hyperaemia  1  2/15 (13.33%)  1/15 (6.67%)  1/14 (7.14%) 
Eye Pruritus  1  2/15 (13.33%)  0/15 (0.00%)  0/14 (0.00%) 
Eye Pain * 1  1/15 (6.67%)  3/15 (20.00%)  1/14 (7.14%) 
Hypotony of Eye  1  1/15 (6.67%)  2/15 (13.33%)  0/14 (0.00%) 
Conjunctival Oedema * 1  1/15 (6.67%)  1/15 (6.67%)  1/14 (7.14%) 
Maculopathy  1  1/15 (6.67%)  1/15 (6.67%)  0/14 (0.00%) 
Cataract Subscapular  1  1/15 (6.67%)  1/15 (6.67%)  0/14 (0.00%) 
Conjunctivitis  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Retinal Haemorrhage  1  1/15 (6.67%)  0/15 (0.00%)  1/14 (7.14%) 
Vitreous Floaters * 1  1/15 (6.67%)  0/15 (0.00%)  1/14 (7.14%) 
Cataract Nuclear  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Eye Irritation * 1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Keratoconjunctivitis Sicca  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Optic Atrophy  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Optic Disc Haemorrhage  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Vitreous Haemorrhage  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Posterior Capsule Opacification  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Vision Blurred * 1  0/15 (0.00%)  1/15 (6.67%)  1/14 (7.14%) 
Anterior Chamber Inflammation  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Corneal Erosion  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Eyelid Cyst  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Iritis  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Retinal Degeneration  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Retinal Depigmentation  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Visual Impairment * 1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Vitreous Disorder  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Vitreous Opacities  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Conjunctival Granuloma  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Dry Eye * 1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Episcleritis  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Eyelid Ptosis  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Iridocyclitis  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Macular Oedema  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Retinal Aneurysm  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Scleral Disorder  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders       
Abdominal Pain Lower * 1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Dyspepsia * 1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Haemorrhoids * 1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Nausea * 1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
General disorders       
Influenza Like Illness * 1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Immune system disorders       
Seasonal Allergy * 1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Infections and infestations       
Pneumonia  1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Cholecystitis Infective  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Cystitis  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Pharyngitis Streptococcal  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Herpes Zoster * 1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Hordeolum * 1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Tooth Abscess  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Tooth Infection  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications       
Head Injury * 1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Investigations       
Intraocular Pressure Decreased  1  1/15 (6.67%)  2/15 (13.33%)  0/14 (0.00%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders       
Pain in Extremity * 1  1/15 (6.67%)  0/15 (0.00%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate Cancer  1  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Psychiatric disorders       
Depression  1  0/15 (0.00%)  2/15 (13.33%)  0/14 (0.00%) 
Renal and urinary disorders       
Hypertonic Bladder  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Renal Mass  1  0/15 (0.00%)  1/15 (6.67%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders       
Hyperhidrosis * 1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Surgical and medical procedures       
Strabismus Correction  1  0/15 (0.00%)  0/15 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 14.0
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
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00972374     History of Changes
Other Study ID Numbers: 190342-031D
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: March 13, 2013
Results First Posted: April 24, 2013
Last Update Posted: April 24, 2013