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

NCT ID: NCT01988246

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2020-01-14

Brief Summary

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.

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.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Sham Injection

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DRUG

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

Intravitreal Aflibercept Injection

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.

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Sham

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

Intervention Type: DRUG

Other Intervention Names

Eylea

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Rishi Singh

OTHER

Sponsor Role: lead

Responsible Party

Rishi Singh

staff surgeon / Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rishi Singh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cole Eye Institute, Cleveland Clinic

Locations

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PROMISE Trial

Identifier Type: -

Identifier Source: org_study_id