Trial Outcomes & Findings for NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME) (NCT NCT01331005)

NCT ID: NCT01331005

Last Updated: 2025-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 125 participants
• Primary outcome timeframe: From Baseline to 12 months
• Results posted on: 2025-03-10

Participant Flow

Participant milestones

Measure	Placebo Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Overall Study STARTED	64	61
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Placebo Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	2	3

Baseline Characteristics

NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)

Baseline characteristics by cohort

Measure	Placebo n=64 Participants Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 Participants Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year	Total n=125 Participants Total of all reporting groups
Age, Customized	59 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants
Race/Ethnicity, Customized White	38 participants n=5 Participants	44 participants n=7 Participants	82 participants n=5 Participants
Race/Ethnicity, Customized African American	13 participants n=5 Participants	7 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	12 participants n=5 Participants	5 participants n=7 Participants	17 participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Type of Diabetes Type 1	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Type of Diabetes Type 2	56 participants n=5 Participants	53 participants n=7 Participants	109 participants n=5 Participants
Type of Diabetes Uncertain	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Duration of Diabetes	17 years STANDARD_DEVIATION 11 • n=5 Participants	19 years STANDARD_DEVIATION 11 • n=7 Participants	18 years STANDARD_DEVIATION 11 • n=5 Participants
Hemoglobin A1c	7.9 Percent HbA1c n=5 Participants	8.1 Percent HbA1c n=7 Participants	7.9 Percent HbA1c n=5 Participants
Electronic-Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score	83 units on a scale STANDARD_DEVIATION 7 • n=5 Participants	82 units on a scale STANDARD_DEVIATION 6 • n=7 Participants	83 units on a scale STANDARD_DEVIATION 7 • n=5 Participants
History of Diabetic Macular Edema Treatment yes	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
History of Diabetic Macular Edema Treatment no	36 participants n=5 Participants	31 participants n=7 Participants	67 participants n=5 Participants
History of Panretinal Photocoagulation yes	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
History of Panretinal Photocoagulation no	53 participants n=5 Participants	48 participants n=7 Participants	101 participants n=5 Participants
Optical Coherence Tomography Machine Zeiss Cirrus	41 participants n=5 Participants	37 participants n=7 Participants	78 participants n=5 Participants
Optical Coherence Tomography Machine Heidelberg Spectralis	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants
Optical Coherence Tomography Central Subfield Thickness	218 Microns STANDARD_DEVIATION 25 • n=5 Participants	227 Microns STANDARD_DEVIATION 29 • n=7 Participants	223 Microns STANDARD_DEVIATION 27 • n=5 Participants
Optical Coherence Tomography Retinal Volume	7.7 mm^3 STANDARD_DEVIATION 0.4 • n=5 Participants	7.9 mm^3 STANDARD_DEVIATION 0.6 • n=7 Participants	7.8 mm^3 STANDARD_DEVIATION 0.5 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 12 months

Outcome measures

Measure	Placebo n=64 Participants Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 Participants Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3	0.02 mm3 Interval -0.19 to 0.16	-0.03 mm3 Interval -0.21 to 0.14

SECONDARY outcome

Timeframe: baseline to 12 months

Population: Original 12-month values are not available in 4 eyes of each of nepafenac and placebo groups because 12-month visit was not completed and were imputed from the last available measurement; values at or before first diabetic macular edema treatment were carried forward in 5 and 3 eyes of nepafenac and placebo groups respectively.

Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.

Outcome measures

Measure	Placebo n=64 Participants Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 Participants Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Mean Change in Visual Acuity	-0.3 Letter Score Standard Deviation 6.2	0.2 Letter Score Standard Deviation 5.7

SECONDARY outcome

Timeframe: baseline to 12 months

95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.

Outcome measures

Measure	Placebo n=64 Participants Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 Participants Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Change in OCT Central Subfield Thickness	7 microns Standard Deviation 35	9 microns Standard Deviation 45

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 37 other events

Deaths: 0 deaths

Nepafenac 0.1% Drops

Serious events: 16 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=64 participants at risk Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 participants at risk Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Eye disorders Burning Eyes	0.00% 0/64	1.6% 1/61 • Number of events 1
Eye disorders Chemical Conjunctivitis	1.6% 1/64 • Number of events 1	0.00% 0/61
Eye disorders Corneal Melt	0.00% 0/64	1.6% 1/61 • Number of events 1
Eye disorders Vision Decreased	0.00% 0/64	1.6% 1/61 • Number of events 1
Cardiac disorders Atrial Fibrillation	1.6% 1/64 • Number of events 1	0.00% 0/61
Blood and lymphatic system disorders Hyperglycemia	1.6% 1/64 • Number of events 1	1.6% 1/61 • Number of events 1
Gastrointestinal disorders Bowl Obstruction	0.00% 0/64	1.6% 1/61 • Number of events 1
Gastrointestinal disorders Rectal Bleeding	0.00% 0/64	1.6% 1/61 • Number of events 1
Cardiac disorders Chest Pain	3.1% 2/64 • Number of events 2	1.6% 1/61 • Number of events 1
Gastrointestinal disorders Gallbladder Stones	1.6% 1/64 • Number of events 1	1.6% 1/61 • Number of events 1
Musculoskeletal and connective tissue disorders Hip Fracture	0.00% 0/64	1.6% 1/61 • Number of events 1
Musculoskeletal and connective tissue disorders Shoulder Fracture	1.6% 1/64 • Number of events 1	0.00% 0/61
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/64	1.6% 1/61 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/64	1.6% 1/61 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney Cancer	1.6% 1/64 • Number of events 1	0.00% 0/61
Nervous system disorders Seizures	1.6% 1/64 • Number of events 1	0.00% 0/61
Nervous system disorders Spinal stenosis of unspecified region	1.6% 1/64 • Number of events 1	0.00% 0/61
Nervous system disorders Stroke (cerebrovascular accident)	0.00% 0/64	1.6% 1/61 • Number of events 1
Renal and urinary disorders Chronic kidney disease	0.00% 0/64	1.6% 1/61 • Number of events 1
Surgical and medical procedures Gastric bypass surgery	1.6% 1/64 • Number of events 1	0.00% 0/61
Surgical and medical procedures Removal of foreign body from throat	0.00% 0/64	1.6% 1/61 • Number of events 1
Vascular disorders Aortic stenosis	1.6% 1/64 • Number of events 1	0.00% 0/61
Vascular disorders Arteriovenous fistula	0.00% 0/64	1.6% 1/61 • Number of events 1
Vascular disorders Caratoid artery disease	0.00% 0/64	1.6% 1/61 • Number of events 1
Vascular disorders Hypotension	0.00% 0/64	1.6% 1/61 • Number of events 1

Other adverse events

Measure	Placebo n=64 participants at risk Placebo will be given three times per day for one year Nepafenac Vehicle: Placebo	Nepafenac 0.1% Drops n=61 participants at risk Nepafenac drops will be given three times per day for one year nepafenac 0.1% drops: One drop three times per day for one year
Eye disorders Eye Pain	7.8% 5/64 • Number of events 5	1.6% 1/61 • Number of events 1
Eye disorders Blurred Vision	9.4% 6/64 • Number of events 6	9.8% 6/61 • Number of events 6
Eye disorders Floaters	6.2% 4/64 • Number of events 4	6.6% 4/61 • Number of events 4
Eye disorders Vitreous Hemorrhage	1.6% 1/64 • Number of events 1	6.6% 4/61 • Number of events 4
Eye disorders Cataract	4.7% 3/64 • Number of events 3	4.9% 3/61 • Number of events 3
Cardiac disorders Chest Pain	4.7% 3/64 • Number of events 3	3.3% 2/61 • Number of events 2
Eye disorders Eye Itching	4.7% 3/64 • Number of events 3	0.00% 0/61
General disorders Fall	4.7% 3/64 • Number of events 3	1.6% 1/61 • Number of events 1
Eye disorders Proliferative Diabetic Retinopathy	4.7% 3/64 • Number of events 3	0.00% 0/61
Gastrointestinal disorders Stomach Virus	3.1% 2/64 • Number of events 2	4.9% 3/61 • Number of events 3
Eye disorders Vision Decreased	4.7% 3/64 • Number of events 3	4.9% 3/61 • Number of events 3
Eye disorders Visual Acuity Decreased	1.6% 1/64 • Number of events 1	4.9% 3/61 • Number of events 3

Additional Information

Adam Glassman

Jaeb Center for Health Research

Phone: 813-975-8690

Email: drcrnet@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee Members of the Network can not discuss the trial results until the primary outcome has been made publicly available.
• Publication restrictions are in place

Restriction type: OTHER