Clinical trial NCT01918371: A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Received Anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME)

Brief summary: This retrospective data review study will evaluate anti-VEGF injections for retinal vein occlusion (RVO) or diabetic macular edema (DME).


Eligibility criteria: Inclusion Criteria:

* Macular edema in the study eye due to RVO or DME
* Received an anti-VEGF injection in the study eye on or after June 2010 for RVO and on or after August 2012 for DME

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2
timeFrame: Up to Time of Injection 2 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3
timeFrame: Up to Time of Injection 3 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4
timeFrame: Up to Time of Injection 4 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5
timeFrame: Up to Time of Injection 5 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6
timeFrame: Up to Time of Injection 6 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7
timeFrame: Up to Time of Injection 7 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8
timeFrame: Up to Time of Injection 8 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9
timeFrame: Up to Time of Injection 9 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10
timeFrame: Up to Time of Injection 10 (Up to 4 Years)
measure: Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11
timeFrame: Up to Time of Injection 11 (Up to 4 Years)
Secondary outcomes:
measure: Percentage of Participants With BCVA of 20/40 or Better in the Study Eye
timeFrame: Up to 4 Years
measure: Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
timeFrame: Up to 4 Years
measure: Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
timeFrame: Up to 4 Years
measure: Mean BCVA in the Study Eye
timeFrame: UP to 4 Years
measure: Change From Baseline in BCVA in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Change From Baseline in CRT by OCT in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Time to Improvement of ≥2 Lines in BCVA in the Study Eye
timeFrame: 4 Years
measure: Time to Improvement of ≥3 Lines in BCVA in the Study Eye
timeFrame: 4 Years
measure: Time to Improvement in BCVA to 20/40 or Better in the Study Eye
timeFrame: 4 Years
measure: Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
timeFrame: 4 Years
measure: Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye
timeFrame: 4 Years
measure: Time Between Anti-VEGF Injections in the Study Eye
timeFrame: 4 Years
measure: Number of Intravitreal Anti-VEGF Injections in the Study Eye
timeFrame: 0-6 Months, 7-12 Months, Years 1,2,3
measure: Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye
timeFrame: UP to 4 Years
measure: Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye
timeFrame: Up to 4 Years
measure: Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye
timeFrame: 4 Years
measure: Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye
timeFrame: 4 Years
measure: Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Percentage of Participants With No Change in BCVA From Baseline in the Study Eye
timeFrame: Baseline, Up to 4 Years
measure: Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye
timeFrame: 4 Years
measure: Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye
timeFrame: 4 Years
measure: Percentage of Phakic Patients With Cataract Surgery in the Study Eye
timeFrame: 4 Years
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Jumper JM, Dugel PU, Chen S, Blinder KJ, Walt JG. Anti-VEGF treatment of macular edema associated with retinal vein occlusion: patterns of use and effectiveness in clinical practice (ECHO study report 2). Clin Ophthalmol. 2018 Apr 3;12:621-629. doi: 10.2147/OPTH.S163859. eCollection 2018.