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

Diabetic Retinopathy Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988246
• Other study ID #: PROMISE Trial
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2013
• Est. completion date: January 14, 2020

Study information

• Verified date: May 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 14, 2020
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Cataract
• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Rishi Singh	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Retinal Thickness	The change in macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days	Day 90
Primary	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	Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score	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.	Day 90