Trial · NCT02087085

A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

NCT02087085, Phase 2, Terminated, Allergan; results first posted 2019-04-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration. Trials, record NCT02087085. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02087085

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT number: NCT02087085
Status: Terminated
Phases: Phase 2
Enrollment: 310 participants, actual
Lead sponsor: Allergan
Conditions: Geographic Atrophy, Macular Degeneration
Interventions: 400 µg Brimonidine Implant, Sham
First posted: 2014-03-14
Last updated: 2019-04-23
Other registries' IDs: eudract:2013-003320-36
Results first posted: 2019-04-23

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24	Baseline (Day 1) to Month 24	GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.
Secondary	Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24	Baseline (Day 1) to Month 24	BCVA was measured using an eye chart (ETDRS) and was 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). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Secondary	Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24	Baseline (Day 1) to Month 24	Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was 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). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Other	Change From Baseline in Retinal Sensitivity in the Study Eye	Baseline (Day 1) to Month 24

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24	Baseline (Day 1) to Month 24	Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis at Month 24.	mm^2	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24	Baseline (Day 1) to Month 24	Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.	letters read correctly	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24	Baseline (Day 1) to Month 24	Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.	letters read correctly	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change From Baseline in Retinal Sensitivity in the Study Eye	Baseline (Day 1) to Month 24

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24	400 µg Brimonidine Implant	3.1455	Standard Error 0.1377	mm^2
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24	Sham	3.5044	Standard Error 0.1359	mm^2
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24	400 µg Brimonidine Implant	-10.9	Standard Error 1.0	letters read correctly
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24	Sham	-9.7	Standard Error 1.0	letters read correctly
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24	400 µg Brimonidine Implant	-8.1	Standard Error 1.0	letters read correctly
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24	Sham	-6.7	Standard Error 1.0	letters read correctly

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	400 µg Brimonidine Implant	154
Overall Study	STARTED	Sham	156
Overall Study	COMPLETED	400 µg Brimonidine Implant	34
Overall Study	COMPLETED	Sham	40
Overall Study	NOT COMPLETED	400 µg Brimonidine Implant	120
Overall Study	NOT COMPLETED	Sham	116

Source ClinicalTrials.gov

Adverse events260

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Vitreous floaters	Eye disorders	400 µg Brimonidine Implant	29	154
other	Vitreous floaters	Eye disorders	Sham	1	156
other	Conjunctival haemorrhage	Eye disorders	400 µg Brimonidine Implant	21	154
other	Conjunctival haemorrhage	Eye disorders	Sham	11	156
other	Visual impairment	Eye disorders	400 µg Brimonidine Implant	12	154
other	Visual impairment	Eye disorders	Sham	6	156
other	Eye pain	Eye disorders	400 µg Brimonidine Implant	11	154
other	Eye pain	Eye disorders	Sham	9	156
other	Visual acuity reduced	Eye disorders	400 µg Brimonidine Implant	9	154
other	Visual acuity reduced	Eye disorders	Sham	6	156

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	400 µg Brimonidine Implant	5	154
Total, all-cause mortality	Sham	6	156
Total, other adverse events	400 µg Brimonidine Implant	79	154
Total, other adverse events	Sham	61	156
Total, serious adverse events	400 µg Brimonidine Implant	48	154
Total, serious adverse events	Sham	37	156

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32134802	DERIVED	PubMed
33383315	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
400 µg Brimonidine Implant vs Sham: deaths from any cause	Trial comparisons
400 µg Brimonidine Implant vs Sham: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02087085

GET https://conductscience.org/api/trials/v1/NCT02087085/events?page=2

API reference For AI assistants