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Trial record 49 of 81 for:    CRVO - Central Retinal Vein Occlusion

Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion (WAVE)

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ClinicalTrials.gov Identifier: NCT01710839
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : April 11, 2017
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Charles C Wykoff, PhD, MD, Greater Houston Retina Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions
Interventions Drug: 0.5mg Ranibizumab
Procedure: Targeted Pan Retinal Photocoagulation
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Period Title: Overall Study
Started 24 6
Completed 23 0
Not Completed 1 6
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg Total
Hide Arm/Group Description

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Total of all reporting groups
Overall Number of Baseline Participants 24 6 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 6 participants 30 participants
64.1
(43 to 80)
63.8
(56 to 77)
64.1
(43 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 6 participants 30 participants
Female
11
  45.8%
4
  66.7%
15
  50.0%
Male
13
  54.2%
2
  33.3%
15
  50.0%
RVO Subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 6 participants 30 participants
CRVO
13
  54.2%
4
  66.7%
17
  56.7%
BRVO
9
  37.5%
2
  33.3%
11
  36.7%
HRVO
2
   8.3%
0
   0.0%
2
   6.7%
Prior Anti-VEGF Injections  
Mean (Full Range)
Unit of measure:  Injections
Number Analyzed 24 participants 6 participants 30 participants
10.2
(2 to 34)
10.0
(2 to 41)
10.1
(2 to 41)
ETDRS BCVA Letters   [1] 
Mean (Full Range)
Unit of measure:  ETDRS BCVA Letters
Number Analyzed 24 participants 6 participants 30 participants
51.7
(7 to 77)
55.3
(29 to 71)
52.4
(7 to 77)
[1]
Measure Description: Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.
Central Retinal Thickness  
Mean (Full Range)
Unit of measure:  Micrometers
Number Analyzed 24 participants 6 participants 30 participants
525
(224 to 1240)
471
(272 to 910)
514
(224 to 1240)
1.Primary Outcome
Title Total Number of Intravitreal Injections Over a 12 Month Period
Hide Description Assess the number of intravitreal injections over 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 24 6
Mean (Full Range)
Unit of Measure: injections
8.7
(5 to 12)
9.5
(7 to 12)
2.Primary Outcome
Title Visual Acuity
Hide Description Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.
Time Frame 12 month period
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient withdrew from the study before month 12
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 23 6
Mean (Standard Error)
Unit of Measure: ETDRS BCVA Letters
14.9  (3.4) 10.7  (4.4)
3.Secondary Outcome
Title Retinal Ischemia
Hide Description Quantify change in area of perfused and ischemic retina.
Time Frame 12 month period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Foveal Avascular Zone
Hide Description Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Adverse Events
Hide Description Incidence and severity of adverse events (ocular and non-ocular).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 24 6
Measure Type: Count of Participants
Unit of Measure: Participants
Notable Ocular Events
17
  70.8%
2
  33.3%
Serious Non-Ocular Events
2
   8.3%
0
   0.0%
6.Secondary Outcome
Title Neovascularization of the Iris, Optic Nerve and Elsewhere
Hide Description Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 24 6
Measure Type: Number
Unit of Measure: percentage of patients
8.33 0
7.Secondary Outcome
Title Central Foveal Outcome
Hide Description Mean change in Central Foveal Volume on High Resolution OCT.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient withdrew from the study before month 12
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 23 6
Mean (Standard Deviation)
Unit of Measure: cubic millimeters
-0.15  (.21) -0.15  (.20)
8.Secondary Outcome
Title Aqueous VEGF Levels
Hide Description VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Visual Field
Hide Description Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.
Time Frame 6 and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14)
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description:

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

Overall Number of Participants Analyzed 11 3
Mean (Standard Error)
Unit of Measure: square degrees
Month 6 -1269  (180) 102  (423)
Month 12 -1628  (353) -1875  (326)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Hide Arm/Group Description

Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.

0.5mg Ranibizumab: intravitreal injections

Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography

Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

0.5mg Ranibizumab: intravitreal injections

All-Cause Mortality
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/24 (8.33%)      0/6 (0.00%)    
Cardiac disorders     
Bradycardia   1/24 (4.17%)  1 0/6 (0.00%)  0
Vascular disorders     
Hemorrhoids with rectal bleeding   1/24 (4.17%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab Ranibizumab 0.5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/24 (70.83%)      2/6 (33.33%)    
Eye disorders     
Glaucoma suspect   1/24 (4.17%)  1 1/6 (16.67%)  1
Cataract progression   3/24 (12.50%)  3 1/6 (16.67%)  1
Visual distortion   8/24 (33.33%)  8 0/6 (0.00%)  0
Posterior vitreous detachment   3/24 (12.50%)  3 0/6 (0.00%)  0
Vitreous hemorrhage   1/24 (4.17%)  1 0/6 (0.00%)  0
Epiretinal membrane   1/24 (4.17%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Charles C Wykoff, PhD, MD
Organization: Retina Consultants of Houston
Phone: 713-524-3434
Publications:
Responsible Party: Charles C Wykoff, PhD, MD, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT01710839     History of Changes
Other Study ID Numbers: 12246
First Submitted: October 17, 2012
First Posted: October 19, 2012
Results First Submitted: February 22, 2017
Results First Posted: April 11, 2017
Last Update Posted: September 8, 2017