N/A
N=323
A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular Edema
Retinal Vein Occlusion · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT01918371 ↗Enrolled (actual)
323
Serious AEs
7.5%
Results posted
May 2016
Primary outcome: Primary: 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 — 26.09; 16.35 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Anti-VEGF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
26.09; 16.35 | — |
| PRIMARY 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 |
28.81; 16.36 | — |
| PRIMARY 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 |
26.56; 17.54 | — |
| PRIMARY 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 |
36.59; 22.11 | — |
| PRIMARY 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 |
25.47; 19.48 | — |
| PRIMARY 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 |
32.29; 20.00 | — |
| PRIMARY 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 |
25.97; 18.75 | — |
| PRIMARY 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 |
32.81; 24.39 | — |
| PRIMARY 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 |
28.57; 22.22 | — |
| PRIMARY 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 |
28.30; 38.89 | — |
| SECONDARY Percentage of Participants With BCVA of 20/40 or Better in the Study Eye |
53.24; 54.89; 53.19; 53.33; 50.35; 51.94 | — |
| SECONDARY Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye |
50.38; 28.81; 56.72; 26.23; 53.10; 29.46 | — |
| SECONDARY 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 |
70.06; 59.86; 73.25; 57.82; 71.52; 58.33 | — |
| SECONDARY Mean BCVA in the Study Eye |
10.6; 11.8; 12.7; 12.8; 13.0; 12.9 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye |
10.6; 11.8; 1.6; 1.0; 1.9; 1.3 | — |
| SECONDARY Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye |
40.29; 30.08; 40.43; 35.56; 40.43; 29.46 | — |
| SECONDARY Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye |
25.90; 14.29; 28.37; 20.00; 25.53; 17.83 | — |
| SECONDARY Change From Baseline in CRT by OCT in the Study Eye |
499.1; 413.4; -159.5; -44.7; -158.6; -62.1 | — |
| SECONDARY Time to Improvement of ≥2 Lines in BCVA in the Study Eye |
4.6667; 7.1500 | — |
| SECONDARY Time to Improvement of ≥3 Lines in BCVA in the Study Eye |
7.2167; 9.1000 | — |
| SECONDARY Time to Improvement in BCVA to 20/40 or Better in the Study Eye |
2.3167; 3.3667 | — |
| SECONDARY Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye |
2.5333; 7.9333 | — |
| SECONDARY 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 |
7.6167; 9.8000 | — |
| SECONDARY Time Between Anti-VEGF Injections in the Study Eye |
1.1; 1.5; 1.1; 1.6; 1.4; 1.7 | — |
| SECONDARY Number of Intravitreal Anti-VEGF Injections in the Study Eye |
4.4; 4.0; 3.3; 2.8; 7.1; 5.8 | — |
| SECONDARY Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye |
33.33; 47.44 | — |
| SECONDARY Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye |
2.67; 0.0; 13.33; 25.26; 4.00; 0.0 | — |
| SECONDARY Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye |
20.00; 44.87 | — |
| SECONDARY Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye |
5.45; 13.46 | — |
| SECONDARY Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye |
13.67; 15.79; 14.18; 21.48; 20.57; 23.26 | — |
| SECONDARY Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye |
58.99; 45.86; 61.70; 53.33; 55.32; 47.29 | — |
| SECONDARY Percentage of Participants With No Change in BCVA From Baseline in the Study Eye |
17.99; 34.59; 14.89; 19.26; 16.31; 25.58 | — |
| SECONDARY Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye |
0.61; 0.64 | — |
| SECONDARY Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye |
1.21; 0.00 | — |
| SECONDARY Percentage of Phakic Patients With Cataract Surgery in the Study Eye |
17.0; 15.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01918371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.