Performance Assessment Tests in Working Individuals With DME Following Treatment With Ranibizumab

NCT02107131 | Completed Phase 4 Results

• 1 other identifier: ML29184s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• A Change Between Two Time Points is Reported for Maximum Reading Speed

  A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.

  Month 12

Secondary Outcomes (3)

• Change in Activity Productivity

  Month 12

• Change in Visual Acuity

  Month 12

• Change in Contrast Sensitivity

  12 months

Study Arms (2)

Monthly Intravitreal ranibizumab 0.3mg

ACTIVE COMPARATOR

Monthly Intravitreal ranibizumab 0.3mg injections.

Drug: Intravitreal ranibizumab 0.3mg

PRN Intravitreal ranibizumab 0.3mg

ACTIVE COMPARATOR

PRN Intravitreal ranibizumab 0.3mg injections.

Drug: Intravitreal ranibizumab 0.3mg

Interventions

Intravitreal ranibizumab 0.3mg DRUG

Monthly Intravitreal ranibizumab 0.3mg; PRN Intravitreal ranibizumab 0.3mg

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age 18 ≤ x ≤ 65 years and currently employed at the baseline study visit
• Diagnosis of diabetes mellitus (type 1 or 2)
• o Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for treatment of diabetes
• Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes
• Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
• Central diabetic macular edema present on clinical examination or or evidence indicating disease activity on spectral domain OCT.
• Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
• Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

You may not qualify if:

• Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
• Participation in another ocular investigation or trial simultaneously
• Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110)
• Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
• Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema
• An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy)
• Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
• Evidence of active neovascularization of the iris or retina
• Evidence of central atrophy or fibrosis in the study eye
• Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
• Previous use of intraocular or periocular corticosteroids in the study eye in the previous 120 days
• Previous treatment with anti-angiogenic drugs in the study eye i.e. pegaptanib sodium, bevacizumab, ranibizumab, aflibercept within 120 days prior to baseline
• History of vitreous surgery in the study eye
• History of cataract surgery within 3 months of enrollment.
• History of YAG capsulotomy within 2 months of enrollment.

Sponsors & Collaborators

• California Retina Consultants: lead

Study Sites (6)

California Retina Consultants - Bakersfield

Bakersfield, California, 93039, United States

Location

California Retina Consultants

Oxnard, California, 93454, United States

Location

California Retina Consultants

Palmdale, California, 93551, United States

Location

California Retina Consultants - Santa Barbara Office

Santa Barbara, California, 93103, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

California Retina Consultants

Visalia, California, 93277, United States

Location

Results Point of Contact

• Title: Director of Research
• Organization: California Retina Consultants

gabe@californiaretina.com

8059631648

Study Officials

• Gabriel Gordon, PhD

  California Retina Consultants

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 8, 2014
• Study Start: March 13, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-11

Locations

US (6)