A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ophthotech Corporation

ClinicalTrials.gov Identifier:

NCT01089517

First received: March 12, 2010

Last updated: April 6, 2017

Last verified: April 2017

History of Changes

Results First Received: November 13, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator, Outcomes Assessor; Primary Purpose: Treatment
Condition:	Age-Related Macular Degeneration
Interventions:	Drug: E10030 plus Lucentis Drug: Lucentis

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled 449 patients at approximately 69 centers in North America, South America, Europe and Israel.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lucentis	Sham/Lucentis 0.5 mg
E10030 0.3 mg/Lucentis 0.5 mg	E10030 0.3 mg/Lucentis 0.5 mg
E10030 1.5 mg/Lucentis 0.5 mg	E10030 1.5 mg/Lucentis 0.5 mg

Participant Flow: Overall Study

	Lucentis	E10030 0.3 mg/Lucentis 0.5 mg	E10030 1.5 mg/Lucentis 0.5 mg
STARTED	148	149	152
COMPLETED	144	144	147
NOT COMPLETED	4	5	5

Baseline Characteristics

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Lucentis	Sham/Lucentis 0.5 mg
E10030 Low Dose Plus Lucentis	E10030 0.3 mg/Lucentis 0.5 mg
E10030 High Dose Plus Lucentis	E10030 1.5 mg/Lucentis 0.5 mg
Total	Total of all reporting groups

Baseline Measures

	Lucentis	E10030 Low Dose Plus Lucentis	E10030 High Dose Plus Lucentis	Total
Overall Participants Analyzed [Units: Participants]	148	149	152	449

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Between 18 and 65 years	8 5.4%	10 6.7%	11 7.2%	29 6.5%
>=65 years	140 94.6%	139 93.3%	141 92.8%	420 93.5%

Age [Units: Years] Mean (Standard Deviation)	78.0 (7.98)	77.6 (8.19)	77.8 (8.36)	77.8 (8.16)

Sex: Female, Male [Units: Participants] Count of Participants
Female	93 62.8%	90 60.4%	92 60.5%	275 61.2%
Male	55 37.2%	59 39.6%	60 39.5%	174 38.8%

Region of Enrollment [Units: Participants]
United States	47	51	53	151
Europe	87	85	82	254
Israel	10	10	14	34
South America	4	3	3	10

Outcome Measures

Show All Outcome Measures

1. Primary:

Mean Change in Visual Acuity From Baseline at the Week 24 Visit [ Time Frame: 24 Weeks ]

Show Outcome Measure 1

2. Secondary:

The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit [ Time Frame: 24 weeks ]

Show Outcome Measure 2

3. Secondary:

Proportion of Patients With at Least 1 Adverse Event [ Time Frame: 24 weeks ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No individual site or investigator may publish or present any results from the trial until a joint, multi center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however, approval will be at the sole discretion of the Sponsor.

Results Point of Contact:

Name/Title: Jeffrey Nau
Organization: Ophthotech
phone: 646-573-7045
e-mail: jeff.nau@ophthotech.com

Responsible Party:	Ophthotech Corporation
ClinicalTrials.gov Identifier:	NCT01089517 History of Changes
Other Study ID Numbers:	OPH1001
Study First Received:	March 12, 2010
Results First Received:	November 13, 2013
Last Updated:	April 6, 2017

To Top