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Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (PROMISE)

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ClinicalTrials.gov Identifier: NCT01988246
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Rishi Singh, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Diabetic Retinopathy
Interventions Drug: Aflibercept
Drug: Sham
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection
Hide Arm/Group Description

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection Total
Hide Arm/Group Description

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
66
(47 to 80)
66
(53 to 80)
66
(47 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
10
  66.7%
6
  40.0%
16
  53.3%
Male
5
  33.3%
9
  60.0%
14
  46.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Hispanic or Latino
2
  13.3%
3
  20.0%
5
  16.7%
Not Hispanic or Latino
13
  86.7%
12
  80.0%
25
  83.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  40.0%
3
  20.0%
9
  30.0%
White
6
  40.0%
10
  66.7%
16
  53.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  20.0%
2
  13.3%
5
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Number of Participants With Ocular and Non-Ocular Adverse Events
Hide Description Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection
Hide Arm/Group Description:

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 Ocular Adverse Event
11
  73.3%
10
  66.7%
At least 1 Non-Ocular Adverse Event
5
  33.3%
3
  20.0%
2.Secondary Outcome
Title Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
Hide Description Change from baseline in best-corrected visual acuity (BCVA) score and BCVA score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study) There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection
Hide Arm/Group Description:

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: Number of Letters Read Correctly
8.52
(4.26 to 12.78)
9.88
(5.54 to 14.22)
3.Other Pre-specified Outcome
Title Change From Baseline in Retinal Thickness
Hide Description The change in macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection
Hide Arm/Group Description:

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: Microns
50.32
(14.49 to 86.15)
18.48
(0.87 to 36.09)
Time Frame Up to 90 days following each surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham Injection Intravitreal Aflibercept Injection
Hide Arm/Group Description

Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.

Sham: Sham injection. No actual injection. No medication is used.

Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.

Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.

All-Cause Mortality
Sham Injection Intravitreal Aflibercept Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Sham Injection Intravitreal Aflibercept Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   2/15 (13.33%)   3/15 (20.00%) 
Eye disorders     
Paracentesis   0/15 (0.00%)  2/15 (13.33%) 
Gastrointestinal disorders     
Cough/Vomiting   0/15 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Rash and Swelling on Limbs   2/15 (13.33%)  0/15 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Injection Intravitreal Aflibercept Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   14/15 (93.33%)   10/15 (66.67%) 
Eye disorders     
Foreign Body Sensation * [1]  3/15 (20.00%)  3/15 (20.00%) 
Corneal Edema * [2]  0/15 (0.00%)  1/15 (6.67%) 
Eye Irritation/Pain * [3]  2/15 (13.33%)  2/15 (13.33%) 
Eye Itching * [4]  1/15 (6.67%)  2/15 (13.33%) 
Lacrimation Increased * [5]  1/15 (6.67%)  1/15 (6.67%) 
Blurred Vision * [6]  4/15 (26.67%)  2/15 (13.33%) 
Photophobia * [7]  3/15 (20.00%)  0/15 (0.00%) 
Floaters * [8]  4/15 (26.67%)  2/15 (13.33%) 
*
Indicates events were collected by non-systematic assessment
[1]
Foreign Body Sensation of Eye
[2]
Corneal Swelling
[3]
Eye irritation and pain
[4]
Eye Itching
[5]
Eye Tearing
[6]
Blurred Vision
[7]
Light Sensitivity
[8]
Floaters in Vision
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rishi Singh, MD
Organization: Cole Eye Institute - Cleveland Clinic
Phone: 216-445-9497
EMail: singhr@ccf.org
Layout table for additonal information
Responsible Party: Rishi Singh, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01988246    
Other Study ID Numbers: PROMISE Trial
First Submitted: October 30, 2013
First Posted: November 20, 2013
Results First Submitted: March 10, 2020
Results First Posted: May 22, 2020
Last Update Posted: May 22, 2020