Trial Outcomes & Findings for Avastin for PDR (Proliferative Diabetic Retinopathy) (NCT NCT01270542)
NCT ID: NCT01270542
Last Updated: 2017-08-17
Results Overview
Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 months after last surgery
Results posted on
2017-08-17
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Avastin Injection Group (AIG)
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Sham Injection Group (SIG)
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
|---|---|---|
|
Overall Study
STARTED
|
10 10
|
9 10
|
|
Overall Study
COMPLETED
|
9 9
|
8 9
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Avastin for PDR (Proliferative Diabetic Retinopathy)
Baseline characteristics by cohort
| Measure |
Avastin Injection Group (AIG)
n=10 Eyes
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Sham Injection Group (SIG)
n=10 Eyes
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Total
n=20 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
53 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Eyes
n=14 Eyes
|
6 Eyes
n=23 Eyes
|
8 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
8 Eyes
n=14 Eyes
|
4 Eyes
n=23 Eyes
|
12 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: 3 months after last surgeryComparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=10 Eyes
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Sham Injection
n=10 Eyes
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
|---|---|---|
|
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
Vitreous VEGF levels
|
0 pg/mL
Interval 0.0 to 559.0
|
373 pg/mL
Interval 0.0 to 1073.0
|
|
The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR
Aqueous VEGF levels
|
13 pg/mL
Interval 0.0 to 1652.0
|
0 pg/mL
Interval 0.0 to 868.0
|
SECONDARY outcome
Timeframe: 3 months after last surgery.Outcome measures
| Measure |
Avastin (Bevacizumab)
n=10 Eyes
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Sham Injection
n=10 Eyes
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
|---|---|---|
|
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Cataract
|
1 Eyes
|
1 Eyes
|
|
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Vitreous hemorrhage
|
0 Eyes
|
1 Eyes
|
|
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Ischemia
|
0 Eyes
|
2 Eyes
|
|
Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.
Glaucoma
|
0 Eyes
|
1 Eyes
|
SECONDARY outcome
Timeframe: 3 months from last surgeryMeasured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)
Outcome measures
| Measure |
Avastin (Bevacizumab)
n=10 Eyes
Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
Sham Injection
n=10 Eyes
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.
|
|---|---|---|
|
Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.
|
-0.18 logMAR
Interval -2.0 to 1.0
|
0 logMAR
Interval -1.0 to 4.4
|
Adverse Events
Avastin Injection Group (AIG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Injection Group (SIG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elliott Sohn
Doheny Eye Institute/USC/University of Iowa
Phone: 319-356-3185
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place