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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01988246
First received: October 30, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

To determine the safety and efficacy of intravitreal Aflibercept (Eylea) injection in patients with diabetic retinopathy in the prevention of macular edema following cataract surgery.


Condition Intervention Phase
Diabetic Retinopathy
Drug: Aflibercept
Drug: Sham
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Safety and Efficacy [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
    Incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between treatment arms.


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Change from baseline in best-corrected visual acuity (BCVA) score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study)


Other Outcome Measures:
  • Macular Edema [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham
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.
Drug: Sham
Sham injection. No actual injection. No medication is used.
Other Name: Sham
Active Comparator: Intravitreal Aflibercept Injection
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
Drug: 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.
Other Name: Eylea

Detailed Description:

Diabetic retinopathy patients who are at risk of developing macular edema (defined as ≥ 30 % increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery. Diabetic patients are defined as those who have either Type 1 or Type 2 diabetes. The patients must have either mild, moderate, or severe non proliferative retinopathy or treated proliferative retinopathy. Patients must be 18 years of age and older, of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens into the lens capsule.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A patient must meet the following criteria to be eligible for inclusion in the study:

    1. Must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule
    2. History of Type I or Type II diabetes
    3. NPDR: non-proliferative diabetic retinopathy (mild, moderate, or severe) or inactive proliferative disease in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale
    4. Willing and able to comply with clinic visits and study-related procedures
    5. Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)
    6. Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center
    7. Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
    8. Patients must have visual acuity of 20/20-20/200

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

  1. Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator
  2. Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision other that diabetic retinopathy
  3. Active proliferative diabetic retinopathy in the study eye
  4. Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant)
  5. Patients who have received corneal transplants in the study eye
  6. Patients with current or history of chronic or recurrent ocular infections or inflammation in the study eye
  7. Patients with a visually nonfunctional fellow eye based upon the assessment by the investigator
  8. Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis
  9. Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day
  10. Use of systemic steroids, NSAIDS (non-steroidal anti-inflammatory drugs), anti-VEGF agents within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted.
  11. Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
  12. Treatment with intraocular or periocular steroids in the study eye within 3 months prior to surgery
  13. Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted)
  14. Intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye within 6 months of the pre-operative baseline visit
  15. Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
  16. Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit
  17. Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either medical or surgical intervention during the 90 day study period.
  18. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  19. Pregnant or breast-feeding women -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988246

Contacts
Contact: Rishi Singh, M.D. 216-445-9497 singhr@ccf.org
Contact: Kathi Dastoli, RN,CCRC 216-445-5248 DASTOLK@ccf.org

Locations
United States, Ohio
Cole Eye Institute, Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rishi Singh , M.D.    216-445-9497    singhr@ccf.org   
Contact: Kathi Dastoli, RN,CCRC    216-445-5248    DASTOLK@ccf.org   
Principal Investigator: Rishi Singh, M.D.         
Sponsors and Collaborators
The Cleveland Clinic
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Rishi Singh, M.D. Cole Eye Institute, Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01988246     History of Changes
Other Study ID Numbers: PROMISE Trial
Study First Received: October 30, 2013
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Diabetes
Diabetic Retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Macular Edema
Retinal Diseases
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014