Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV Due to AMD

NCT03393767 | Completed Phase 4

• 1 other identifier: OCT-2010-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.

Conditions

Choroidal Neovascularization; Age Related Macular Degeneration

Keywords

CNV; AMD; ranibizumab

Outcome Measures

Primary Outcomes (1)

• Change in CNV activity (any fluid) as assessed by High Resolution OCT

  The primary objective is to evaluate the time course of early re-activation of CNV assessed by High Resolution OCT.

  12 month OCT Assessment

Secondary Outcomes (4)

• To evaluate the correlation between activation of CNV evaluated by OCT (any fluid) and changes of BCVA.

  12 month

• To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on BCVA changes at month 12.

  12 months

• To evaluate the effect of OCT-guided up to 2-weekly dosing of ranibizumab on the total number of injections needed within the 12 months observation period.

  12 months

• To evaluate the safety and tolerability of up to 2-weekly dosing of ranibizumab by determining the rates of adverse events and serious adverse events at month 12.

  12 months

Study Arms (1)

prospective 1- Arm

OTHER

OCT-guided high frequency intravitreal ranibizumab 0.5mg

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal injection

Also known as: Lucentis

prospective 1- Arm

Eligibility Criteria

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

You may qualify if:

• Male or female patients ≥ 50 years of age.
• Patients with active primary subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
• Evidence that CNV extends under the geometric center of the foveal avascular zone.
• Total CNV area encompassed within the lesion must be ≥ 50% of total lesion area.
• The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
• Patients who have a BCVA of 20/32 to 20/320 (letter score of 78 to 25 letters) in the study eye using ETDRS charts.
• Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
• Willing and able to comply with study procedures.

You may not qualify if:

• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
• Structural damage to the center of the macula (beside CNV) in the study eye.
• Presence of a retinal pigment epithelial tear involving the macula in the study eye.
• Patients with angioid streaks or precursors of CNV in either eye due to other causes.
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
• Vitreous hemorrhage, history of rhegmatogenous retinal detachment or macular hole.
• Active intraocular inflammation (grade trace or above) in the study eye.
• Any active infection involving ocular adnexa.
• History of uncontrolled glaucoma in the study eye.
• Aphakia with absence of the posterior capsule in the study eye.
• Any prior treatment in the study eye with verteporfin, subfoveal focal laser photo-coagulation, vitrectomy, transpupillary thermotherapy, intravitreally applied drugs.
• History of submacular surgery or other surgical intervention for AMD in the study eye.
• Extracapsular extraction of cataract within 3 months preceding Baseline.
• Previous violation of posterior capsule in the study eye (unless YAG capsulotomy).
• History of Stroke.

Sponsors & Collaborators

• Vista Klinik: lead

Study Sites (1)

Vista Klinik

Binningen, 4102, Switzerland

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christian Pruente, MD

  Vista Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Christian Pruente

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: January 8, 2018
• Study Start: December 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

CH (1)