Geographic Atrophy and Intravitreal Ranibizumab Injections

NCT02372916 | Unknown

• 1 other identifier: 14-8235
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity. Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.

Conditions

Age-related Macular Degeneration; Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Geographic atrophy area progression

  To assess the association between rate of geographic atrophy (GA) progression in age-related macular degeneration (AMD) and repeated intravitreal ranibizumab injections

  Every 6 month for total of 2 years

Secondary Outcomes (2)

• Geographic atrophy morphological characteristics

  Every 6 month for total of 2 years

• Concordance of GA enlargement rate between the two eyes

  Every 6 month for total of 2 years

Study Arms (3)

Dry AMD

Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)

Wet AMD and treatment-naive

Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients

Drug: Ranibizumab

Wet AMD with history of intravitreal injections

Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

The medication Ranibizumab is routine standard of care for patients with wet AMD, and this is not an aspect of the study that is considered novel intervention

Wet AMD and treatment-naive; Wet AMD with history of intravitreal injections

Eligibility Criteria

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

Study Population

Patients with both dry and wet-AMD

You may qualify if:

• Age \> 50 years old
• Patients with pre-existing GA secondary to AMD NOT requiring intravitreal injections (i.e. Dry AMD)
• Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and are treatment-naïve patients
• Patients with pre-existing GA and CNV secondary to AMD requiring intravitreal injections (i.e. Exudative AMD) and have received previous intravitreal injections.
• Able to maintain steady fixation in foveal and parafoveal area for fundus imaging Geographic atrophy (GA), both foveal-sparing and foveal GA. Foveal-sparing GA is defined as no GA within 250μm of the centre (Sunness et al. 1999)
• Area of GA can be imaged in its entirety and is not contiguous with areas of peripapillary atrophy
• Adequate media clarity for quality fundus images

You may not qualify if:

• Inability to undergo study procedures (e.g. contraindications to intravitreal injections) or attend follow-up visits CNV attributable to other causes than AMD
• Active intraocular inflammation
• Any other retinopathy, including diabetic retinopathy, retinal venous occlusion, epiretinal membrane

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Crystal Cheung, MD

CONTACT

416-603-5376; cheuncsy@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

CA (1)