Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration

Neovascular Age Related Macular Degeneration Clinical Trial

Official title:

Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764738
• Other study ID #: FVF4495s
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2020
• Source: Retina Macula Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• Age greater or equal to 50 years old.

• Patients with active neovascular AMD

Exclusion Criteria:

• Pregnancy (Positive pregnancy test) or lactation.

• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

• Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)

• Previous PDT therapy

• Previous intravitreal steroid therapy within last 3 months

• Previous anti-VEGF therapy in the past month

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Device:
• OCT, Multifocal ERG, Microperimetry
OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12. Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab. Multifocal ERG done at the same monthly visits as the microperimetry.

Drug:
• Ranibizumab Ophthalmic
0.5 mg ranibizumab vs 2.0 mg ranibizumab

Locations

Country	Name	City	State
United States	Retina Macula Institute	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Retina Macula Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multifocal Electroretinography N1-P1 Amplitude	As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).	One Year
Primary	Microperimetry Mean Sensitivity		One Year
Secondary	Best Corrected Visual Acuity		One Year
Secondary	Central Foveal Thickness on Optical Coherence Tomography		One Year