Neovascular Morphology and Persistent Disease Activity Among Patients With NV AMD

NCT02367365 | Completed

• 1 other identifier: Pro00055232
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision loss among people over 65. Intravitreal injections with drugs that block VEGF have revolutionized treatment of NV AMD. However, less than 40% of treated patients have clinically significant imporovement in vision. In this study, we will determine the relative frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD patient population, and 2) a population of patients who develop recurrent NV AMD activity while off treatment and assess the frequency of persistent disease activity (PDA) according to specific neovascular morphologic subtypes. This information will clarify the scope of the PDA problem and will identify patients with PDA who may benefit from additional therpeutic strategies.

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration; anti-vascular endothelial growth factor; neovascular lesion morphology; indocyanine green angiography; persistent disease activity

Outcome Measures

Primary Outcomes (2)

• Frequency of ICG neovascular subtypes

  4-6 weeks post loading dose

• Percentage of each neovascular subtype exhibiting persistent disease activity

  4-6 weeks post loading dose

Study Arms (2)

Treatment Naive NVAMD Patients

Patients with treatment naive NVAMD diagnosed in the last three months

Other: No Intervention

Newly Reactivated NVAMD Patients

Patients with newly reactivated NVAMD which has been previously quiescent off treatment

Other: No Intervention

Interventions

No Intervention OTHER

No intervention

Treatment Naive NVAMD Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with treatment naive NVAMD or newly reactivated NVAMD

You may qualify if:

• Diagnosis of either treatment naive NVAMD or newly reactivated NVAMD which has been previously quiescent off treatment
• Men and women aged 50 years or older
• Able to provide written informed consent

You may not qualify if:

• Potential study eye with ongoing (within previous 6 months of diagnosis of NVAMD disease activity) treatment for CNV, including anti-VEGF medications, corticosteroids, photodynamic therapy, thermal laser photocoagulation, transpupillary thermotherapy, or pneumatic displacement of macular hemorrhage
• CNV secondary to causes other than AMD
• Known or suspected sensitivity or allergy to ICG dye
• Known or suspected sensitivity or allergy to fluorescein dye
• Significant medial opacity (e.g. cataract) precluding clincial imaging adequate for interpretation
• Prior history of vitrectomy surger in potential study eye

Sponsors & Collaborators

• Duke University: lead
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Scott Cousins, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2017-11

Locations

US (1)