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

NCT01988246 | Completed Phase 1 Results DMC

• 1 other identifier: PROMISE Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

Diabetes; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ocular and Non-Ocular Adverse Events

  Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.

  Day 90

Secondary Outcomes (1)

• Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score

  Day 90

Other Outcomes (1)

• Change From Baseline in Retinal Thickness

  Day 90

Study Arms (2)

Sham Injection

SHAM COMPARATOR

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.

Drug: Sham

Intravitreal Aflibercept Injection

ACTIVE COMPARATOR

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.

Drug: Aflibercept

Interventions

Aflibercept 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.

Also known as: Eylea

Intravitreal Aflibercept Injection

Sham DRUG

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

Sham Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• History of Type I or Type II diabetes
• 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
• Willing and able to comply with clinic visits and study-related procedures
• Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB)
• 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
• Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam
• Patients must have visual acuity of 20/20-20/200

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from the study:
• Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator
• 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
• Active proliferative diabetic retinopathy in the study eye
• Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant)
• Patients who have received corneal transplants in the study eye
• Patients with current or history of chronic or recurrent ocular infections or inflammation in the study eye
• Patients with a visually nonfunctional fellow eye based upon the assessment by the investigator
• Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis
• 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
• 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.
• Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery
• Treatment with intraocular or periocular steroids in the study eye within 3 months prior to surgery
• 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)
• Intravitreal anti-VEGF (vascular endothelial growth factor) treatment in the study eye within 6 months of the pre-operative baseline visit

Sponsors & Collaborators

• Rishi Singh: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Cole Eye Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

aflibercept; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Rishi Singh, MD
• Organization: Cole Eye Institute - Cleveland Clinic

singhr@ccf.org

216-445-9497

Study Officials

• Rishi Singh, M.D.

  Cole Eye Institute, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: staff surgeon / Sponsor-Investigator

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: April 25, 2018
• Study Completion: January 14, 2020
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Locations

US (1)