Drugs / pegaptanib sodium

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Macugen 2006-01-31 europa.eu
Approved US (FDA) MACUGEN 2004-09-17 fda.gov

Trials 34 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT01487070 Apr → Jul 2011 proliferative diabetic retinopathy Retina Institute of Hawaii Completed No outcome recorded
Phase 1 NCT00056199 Mar 2003 → Nov 2005 von Hippel-Lindau disease National Eye Institute (NEI) Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT00358423 Jul 2006 → Feb 2007 cystoid macular edema Johns Hopkins University Terminated No outcome recorded
Phase 1/2 NCT00346983 Jun 2006 → Apr 2007 cystoid macular edema Johns Hopkins University Terminated No outcome recorded
Phase 26 trials
Phase 2 NCT01281098 Mar 2010 → Oct 2012 proliferative diabetic retinopathy, type 1 diabetes mellitus, type 2 diabetes mellitus Association for Innovation and Biomedical Research on Light and Image Completed No outcome recorded
Phase 2 NCT00531336 Jul 2006 → Dec 2008 macular degeneration The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery Completed No outcome recorded
Phase 2 NCT00239928 Sep 2005 → Nov 2008 age-related macular degeneration Pfizer Completed No outcome recorded
Phase 2 NCT00088283 May 2004 → ? retinal vein occlusion Eyetech Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00087763 Mar 2004 → May 2006 macular degeneration Eyetech Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00040313 Oct 2002 → Feb 2005 diabetic macular edema Eyetech Pharmaceuticals Completed No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT00605280 Sep 2005 → Nov 2009 diabetic macular edema Pfizer Completed No outcome recorded
Phase 2/3 NCT00215670 Nov 2002 → May 2006 age-related macular degeneration Eyetech Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT00021736 Jul 2001 → Jul 2002 choroidal neovascularization, macular degeneration Eyetech Pharmaceuticals Completed No outcome recorded
Phase 2/3 NCT00321997 May 2001 → Oct 2007 age-related macular degeneration Eyetech Pharmaceuticals Completed No outcome recorded
Phase 35 trials
Phase 3 NCT01589718 Apr 2012 → Mar 2014 proliferative diabetic retinopathy Greater Houston Retina Research Withdrawn No outcome recorded
Phase 3 NCT01189461 Jan 2011 → Jul 2012 diabetic macular edema Pfizer Completed No outcome recorded
Phase 3 NCT01100307 May 2010 → Aug 2012 diabetes mellitus, macular retinal edema Pfizer Completed No outcome recorded
Phase 3 NCT00788177 Nov 2008 → Mar 2012 age-related macular degeneration Klinikum Ludwigshafen Unknown No outcome recorded
Phase 3 NCT00150202 Jul 2004 → Oct 2006 macular degeneration Pfizer Completed No outcome recorded
Phase 49 trials
Phase 4 NCT01175070 Jan 2011 → Mar 2013 diabetic macular edema University of Oxford Completed No outcome recorded
Phase 4 NCT01573572 Apr 2010 → Nov 2019 age-related macular degeneration, diabetic macular edema, retinal vein occlusion Bausch & Lomb Incorporated Completed No outcome recorded
Phase 4 NCT01486238 Apr 2009 → Jul 2011 diabetic macular edema Valley Retina Institute Completed No outcome recorded
Phase 4 NCT01486771 Nov 2007 → Aug 2013 proliferative diabetic retinopathy Valley Retina Institute Unknown No outcome recorded
Phase 4 NCT00327470 Jul 2006 → Aug 2009 age-related macular degeneration, choroidal neovascularization Pfizer Terminated No outcome recorded
Phase 4 NCT00324116 Jul 2006 → Aug 2008 macular degeneration Pfizer Completed No outcome recorded
Phase 4 NCT00354445 Jun 2006 → ? age-related macular degeneration Eyetech Pharmaceuticals Unknown No outcome recorded
Phase 4 NCT00312351 Apr → Nov 2006 macular degeneration Eyetech Pharmaceuticals Terminated No outcome recorded
Phase 4 NCT00134667 Mar 2005 → Oct 2008 age-related macular degeneration Eyetech Pharmaceuticals Terminated No outcome recorded
Phase not applicable5 trials
NCT00790803 Mar 2009 → Nov 2011 cystoid macular edema, uveitis Wake Forest University Completed No outcome recorded
NCT00709657 Mar 2008 → Jul 2010 macular degeneration Medical University of Vienna Terminated No outcome recorded
NCT00446381 Oct 2006 → Sep 2008 diabetic macular edema, proliferative diabetic retinopathy London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Completed No outcome recorded
NCT00272766 Feb 2006 → May 2007 choroidal neovascularization, histoplasmosis retinitis Barnes Retina Institute Terminated No outcome recorded
NCT00088192 Jul 2004 → ? macular degeneration Eyetech Pharmaceuticals Completed No outcome recorded
Phase not stated1 trial
NCT01487044 diabetic macular edema Retina Institute of Hawaii Available No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT00242580 Comparator Sep 2005 → Jan 2008 age-related macular degeneration, choroidal neovascularization Novartis Pharmaceuticals Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02321267 Background Dec 2014 → Dec 2024 macular degeneration Kagawa University Unknown No outcome recorded
Phase 4 NCT00406107 Comparator Jan 2006 → Dec 2007 occlusion of tributary of retinal vein Palmetto Retina Center, LLC Completed No outcome recorded
Phase not applicable1 trial
NCT01218230 Comparator Dec 2010 → Jul 2012 choroidal neovascularization L.V. Prasad Eye Institute Withdrawn No outcome recorded

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 43 sources stand behind the page.

FieldValueCited text
Known as pegaptanib sodium “Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen \[TM\]) 0.3mg every 6 weeks over a 30 week period.” NCT01175070
19

“OBJECTIVES: To assess the safety and efficacy of intravitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO).” PMID 19365011 Apr 2009

“An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema.” PMID 25187694 Aug 2014

Pegaptanib sodium is an aptamer designed to bind the VEGF 165 isoform with high affinity.” NCT00531336

“Intravitreous Injections of Pegaptanib sodium (Anti-VEGF Pegylated Aptamer)” NCT00312351

Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks for 2 Years” NCT00605280

“Macugen ™ (pegaptanib sodium injection)” NCT00087763

“Macugen ® (pegaptanib sodium)” NCT01486771

pegaptanib sodium (Macugen)” NCT00215670

pegaptanib sodium (Macugen)” NCT00406107

“Macugen (Pegaptanib Sodium)” NCT01487070

“Macugen (Pegaptanib Sodium)” NCT01487044

“Macugen (pegaptanib sodium)” NCT00272766

pegaptanib sodium (Macugen)” NCT00040313

pegaptanib sodium (Macugen)” NCT00324116

pegaptanib sodium (Macugen)” NCT00354445

“Macugen (pegaptanib sodium)” NCT00134667

“Drug: Pegaptanib sodiumNCT00346983

NCT00358423

NCT00239928

Known as 0.3mg Pegaptanib Sodium, Macugen 0.3mg Pegaptanib Sodium, MacugenNCT01589718
Known as EYE001 “Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer)” NCT00040313
2

NCT00056199

NCT00021736

Known as EYEOO1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201421
Known as Macugen “Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study.” PMID 24997182 Jul 2014
15

“The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).” NCT00709657

“Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks for 2 Years” NCT00605280

Macugen ™ (pegaptanib sodium injection)” NCT00087763

“pegaptanib (also called Macugen)” NCT00358423

Macugen ® (pegaptanib sodium)” NCT01486771

Macugen (pegaptanib sodium)” NCT00272766

“pegaptanib sodium (Macugen)” NCT00215670

Macugen (Pegaptanib Sodium)” NCT01487070

Macugen (Pegaptanib Sodium)” NCT01487044

“pegaptanib sodium (Macugen)” NCT00040313

“pegaptanib sodium (Macugen)” NCT00354445

Macugen (pegaptanib sodium)” NCT00134667

“Pegaptanib (Macugen)” NCT00531336

NCT01589718

NCT00446381

Known as Macugen \[TM\] “Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen \[TM\]) 0.3mg every 6 weeks over a 30 week period.” NCT01175070
Known as NX-1838 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201421
Known as pegaptanib “intravitreous pegaptanib 0.3 mg or sham injection.” PMID 21896838 Sep 2011
32

“Macugen (pegaptanib)” NCT00446381

NCT01486771

NCT00531336

NCT00709657

NCT00087763

NCT00088283

NCT01487044

NCT00354445

NCT00088192

NCT01487070

NCT01175070

NCT00790803

NCT00150202

NCT02321267

NCT00321997

NCT01486238

NCT01100307

NCT00040313

NCT01573572

NCT00324116

NCT00312351

NCT00327470

NCT00406107

NCT01189461

NCT01218230

NCT00788177

NCT00272766

NCT00242580

NCT00346983

NCT00215670

NCT00134667

NCT01281098

Known as Pegaptanib na ChEMBL registry synonym — accepted as the source's own label CHEMBL1201421
Action Inhibit “anti-VEGF drug” NCT00021736
Modality Aptamer “EYE001 anti-VEGF aptamerNCT00021736
Route Intravitreal Intravitreal Injections of EYE001” NCT00021736
Target VEGF “EYE001 decreases production of VEGFNCT00056199